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How much does propecia cost

One reason that it's so difficult to deliver large protein drugs orally is how much does propecia cost that these drugs can't pass through the mucus barrier that lines the digestive tract. This means that insulin and most other "biologic drugs" -- drugs consisting of proteins or nucleic acids -- have to be injected or administered in a hospital.A how much does propecia cost new drug capsule developed at MIT may one day be able to replace those injections. The capsule has a robotic cap that spins and tunnels through the mucus barrier when it reaches the small intestine, allowing drugs carried by the capsule to pass into cells lining the intestine."By displacing the mucus, we can maximize the dispersion of the drug within a local area and enhance the absorption of both small molecules and macromolecules," says Giovanni Traverso, the Karl van Tassel Career Development Assistant Professor of Mechanical Engineering at MIT and a gastroenterologist at Brigham and Women's Hospital.In a study appearing today in Science Robotics, the researchers demonstrated that they could use this approach to deliver insulin as well as vancomycin, an antibiotic peptide that currently has to be injected.Shriya Srinivasan, a research affiliate at MIT's Koch Institute for Integrative Cancer Research and a junior fellow at the Society of Fellows at Harvard University, is the lead author of the study.Tunneling throughFor several years, Traverso's lab has been developing strategies to deliver protein drugs such as insulin orally. This is a difficult task because protein drugs tend to be broken down in acidic environment of the digestive tract, and they also have difficulty penetrating the mucus barrier that lines the tract how much does propecia cost. advertisement To overcome those obstacles, Srinivasan came up with the idea of creating a protective capsule that includes a mechanism that can tunnel through mucus, just as tunnel boring machines drill into soil and rock."I thought that if we could tunnel through the mucus, then we could deposit the drug directly on the epithelium," she says.

"The idea is that you would ingest this capsule and the outer layer would dissolve in the digestive tract, exposing all these features that start to churn through the mucus and clear it."The "RoboCap" capsule, which is about the how much does propecia cost size of a multivitamin, carries its drug payload in a small reservoir at one end and carries the tunnelling features in its main body and surface. The capsule is coated with gelatin that can be tuned to dissolve at a specific pH.When the coating dissolves, the change in pH triggers a tiny motor inside the RoboCap capsule to start spinning. This motion helps the capsule to tunnel into the mucus and displace how much does propecia cost it. The capsule is also coated with small studs that brush mucus away, similar to the action of a toothbrush.The spinning motion also helps to erode the compartment that carries the drug, which is gradually released into the digestive tract. advertisement "What the RoboCap does is transiently displace the initial mucus barrier and then enhance absorption by maximizing the dispersion of the drug locally," how much does propecia cost Traverso says.

"By combining all of these elements, we're really maximizing our capacity to provide the optimal situation for the drug to be absorbed."Enhanced deliveryIn tests in animals, the researchers used this capsule to deliver either insulin or vancomycin, a large peptide antibiotic that is used to treat a broad range of s, including skin s as well as s affecting orthopedic implants. With the capsule, the researchers found that how much does propecia cost they could deliver 20 to 40 times more drug than a similar capsule without the tunneling mechanism.Once the drug is released from the capsule, the capsule itself passes through the digestive tract on its own. The researchers found no sign of inflammation or irritation in the digestive tract after the capsule passed through, and they also observed that the mucus layer reforms within a few hours after being displaced by the capsule.Another approach that some researchers have used to enhance oral delivery of drugs is to give them along with additional drugs that help them cross through the intestinal tissue. However, these how much does propecia cost enhancers often only work with certain drugs. Because the MIT team's new approach relies solely on mechanical disruptions to the mucus barrier, it could potentially be applied to a broader set of drugs, Traverso says."Some of the chemical enhancers preferentially work with certain drug molecules," he says.

"Using mechanical methods of administration can potentially enable more drugs to have enhanced how much does propecia cost absorption."While the capsule used in this study released its payload in the small intestine, it could also be used to target the stomach or colon by changing the pH at which the gelatin coating dissolves. The researchers also plan to explore the possibility of delivering other protein drugs such as GLP1 receptor agonist, which is sometimes used to treat type 2 diabetes. The capsules could also be used to deliver topical drugs to treat ulcerative colitis and other inflammatory conditions by maximizing the local concentration of the drugs in the tissue to help treat how much does propecia cost the inflammation.The research was funded in part by the National Institutes of Health and MIT's Department of Mechanical Engineering.Dogs can smell stress from human sweat and breath, a new study by Queen's University Belfast researchers has found.The study involved four dogs from Belfast -- Treo, Fingal, Soot and Winnie -- and 36 people.Researchers collected samples of sweat and breath from participants before and after they did a difficult maths problem. They self-reported their stress levels before how much does propecia cost and after the task and researchers only used samples where the person's blood pressure and heart rate had increased.The dogs were taught how to search a scent line-up and alert researchers to the correct sample. The stress and relaxed samples were then introduced but at this stage the researchers didn't know if there was an odour difference that dogs could detect.In every test session, each dog was given one person's relaxed and stressed samples, taken only four minutes apart.

All of the dogs were able to correctly alert how much does propecia cost the researchers to each person's stress sample.Clara Wilson, a PhD student in the School of Psychology at Queen's, explains. "The findings show that we, as humans, produce different smells through our sweat and breath when we are stressed and dogs can tell this apart from our smell when relaxed -- even if it is someone they do not know."The research highlights that dogs do not need visual or audio cues to pick up on human stress. This is the first study of its kind and it provides evidence that dogs can smell stress from breath and sweat alone, which could be useful when training service dogs and therapy dogs."It also helps to shed more light on the human-dog relationship and adds to our understanding of how dogs how much does propecia cost may interpret and interact with human psychological states."One of the super sniffer canines that took part in the study was Treo, a two-year old Cocker Spaniel. His owner Helen Parks says. "As the owner of a dog that thrives on sniffing, we were delighted and curious to see Treo how much does propecia cost take part in the study.

We couldn't wait to hear the results each week when we collected him. He was always so excited to see the researchers at Queen's and could find his own way to the laboratory."The study made us more aware of a dog's how much does propecia cost ability to use their nose to "see" the world. We believe this study really developed Treo's ability to sense a change in emotion at home. The study reinforced for us that how much does propecia cost dogs are highly sensitive and intuitive animals and there is immense value in using what they do best -- sniffing!. "The research findings have been published in PLOS ONE.

The study was carried out by Clara Wilson (PhD researcher) and Kerry Campbell (MSc student) in the School of how much does propecia cost Psychology. They were supervised by Catherine Reeve, with support on collecting the human physiological measures from Zachary Petzel. Story Source how much does propecia cost. Materials provided by Queen's University Belfast. Note.

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Not a moment too soon, how much does propecia cost yes?. This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, since we are pondering what to do with an extended break on this side of the pond. However, we do hope how much does propecia cost to promenade extensively with the official mascot, hold a listening party or two with Mrs.

Pharmalot, and take lots of naps. And how about you?. The great outdoors is beckoning, which means you can take a ride in the country, how much does propecia cost paddle about a lake, or jump in an ocean. You could fire up the grill and invite some friends (but hide the ketchup if the talk turns to current events), or simply reach out to someone special.

Well, whatever you do, have a grand time. But be safe. Enjoy, and see how much does propecia cost you soon. €¦Senate Democrats are vetting a new, tweaked version of a prescription drug-pricing package as they hurtle toward a September deadline to pass any major reforms, according to STAT.

It remains uncertain that Congress will pass prescription drug-pricing reform as part of a broader domestic policy package being hammered out between Senate Majority Leader Chuck Schumer and moderate Sen. Joe Manchin (D-W.V.), but this week, the chances are looking how much does propecia cost better than ever. Negotiations have come a long way, and a drug-pricing policy is now the most solid plank of a potential deal that both Schumer and Manchin agree on. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!.

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Avodart or propecia for hair loss

Trial Population From April 2021 through June 2021, a total of 224 children 2 to 5 years of age and 150 children 6 to http://www.hr-upshot.com/kamagra-online-no-prescription/ 23 months of age were enrolled in avodart or propecia for hair loss part 1 of the trial (Fig. S2). Among children 2 to 5 years of age, 75 were assigned to receive the 25-μg dose of mRNA-1273, and 149 were assigned to receive the 50-μg dose. All children 6 to 23 months of age (150 participants) were assigned to receive the 25-μg dose. All participants received both injections.

Figure 1. Figure 1. Randomization of Participants 2 to 5 Years of Age and Participants 6 to 23 Months of Age in Part 2 of the Trial. Discontinuation of the trial regimen indicates that a participant who received the first injection did not receive the second injection. In the cohort of 2-to-5-year-olds (Panel A), 51 participants in the mRNA-1273 group and 16 in the placebo group had planned to receive the second injection, but the injection was delayed because of adverse events, illness, or severe acute respiratory syndrome hair loss 2 (hair loss) (the majority of these participants had hair loss disease 2019 [hair loss treatment] or hair loss ).

These participants continued in the ongoing trial, and their data remained blinded. Among the participants who discontinued the trial, 15 in the mRNA-1273 group and 6 in the placebo group received one injection, and 34 and 24 participants, respectively, received the second injection. Among the 2982 participants who continued in the ongoing trial, 2897 had data that remained blinded, and 85 had data that were unblinded (5 received the second injection after unblinding, 79 received a second injection before unblinding, and 1 had not yet received the planned second injection) and were entered in the open-label trial. In the cohort of 6-to-23-month-olds (Panel B), among the participants who discontinued the trial, 3 in the mRNA-1273 group and 5 in the placebo group received the first injection, and 14 and 7 participants, respectively, received the second injection. A total of 156 participants in the mRNA-1273 group and 56 in the placebo group had planned to receive the second injection, and their data remained blinded.

Most of these participants had not reached day 29 after the first injection by the data-cutoff date (February 21, 2022). EUA denotes emergency use authorization.In part 2 of the trial, in the cohort of children 2 to 5 years of age, 3031 of 3040 participants (99.7%) in the mRNA-1273 group and 1007 of 1008 participants (99.9%) in the placebo group received the first injection. 2960 participants (97.4%) and 970 participants (96.2%), respectively, received the second injection (Figure 1). In the cohort of children 6 to 23 months of age, 1760 of 1762 participants (99.9%) assigned to the mRNA-1273 group and 590 of 593 participants (99.5%) assigned to the placebo group received the first injection. 1600 participants (90.8%) in the mRNA-1273 group and 529 (89.2%) in the placebo group received the second injection.

Table 1. Table 1. Demographic and Clinical Characteristics of the Participants in the Safety Population at Baseline (Part 2 of the Trial), Stratified According to Age Cohort and Trial-Group Assignment. The baseline demographic and clinical characteristics of the children in the trial groups were generally balanced and were similar in part 1 (Tables S2 and S3) and part 2 (Table 1 and Table S4) of the trial. Overall, in part 2, the median age of the children in the 2-to-5-year-old cohort was 3.0 years (interquartile range, 2.0 to 4.0).

A total of 76.5% of the participants in this cohort were White, 4.5% were Black, 6.0% were Asian, and 14.2% were Hispanic or Latinx. In the 6-to-23-month-old cohort, the median age was 16.0 months (interquartile range, 13.0 to 20.0). A total of 78.9% of the participants in this cohort were White, 3.1% were Black, 4.9% were Asian, and 13.2% were Hispanic or Latinx. The underrepresentation of Black participants is acknowledged. The median duration of follow-up in the 2-to-5-year-old cohort was 103 days (interquartile range, 83 to 113) after the first injection and 71 days (interquartile range, 49 to 83) after the second injection, and in the 6-to-23-month-old cohort, the corresponding values were 98 days (interquartile range, 76 to 110) and 68 days (interquartile range, 42 to 78).

Safety Figure 2. Figure 2. Solicited Local and Systemic Adverse Reactions in the Cohorts of Children 2 to 5 Years and 6 to 23 Months of Age in Part 2 of the Trial. Shown are the percentages of participants in the two age cohorts (2-to-5-year-olds [Panel A] and 6-to-23-month-olds [Panel B]) in the part 2 solicited safety population (all participants who received at least one injection and had any data collected on solicited adverse reactions) who had a solicited local or systemic adverse reaction within 7 days after the first or second injection. Local adverse reactions of injection-site pain, erythema, swelling (hardness), and axillary or groin swelling or tenderness were assessed in both age cohorts.

Among participants 37 months to 5 years of age, the solicited systemic adverse reactions were fever, headache, fatigue, myalgia, arthralgia, nausea or vomiting, and chills. Among participants 6 to 36 months of age, the solicited systemic adverse reactions were fever, irritability or crying, sleepiness, and loss of appetite. The data-cutoff date was February 21, 2022.Safety data from part 1 of the trial are available in the Part 1 Results section in the Supplementary Appendix and in Tables S5 through S13. In part 2, the incidence of solicited local adverse reactions was higher with mRNA-1273 than with placebo in both age cohorts, and in the mRNA-1273 group, the incidence was higher after the second injection than after the first injection (Figure 2 and Tables S14 through S17). Most local adverse reactions were of grade 1 or 2 and lasted for 1 to 3 days.

Grade 3 events were rare overall but were more frequent after the second injection. The most common grade 3 events were erythema, swelling, and pain among children 2 to 5 years of age and erythema and swelling among children 6 to 23 months of age. Systemic adverse reactions after either injection were more common in the mRNA-1273 group than in the placebo group (Figure 2 and Tables S18 and S19). The most common systemic adverse reaction among children 37 months to 5 years of age was fatigue. Among children 6 to 36 months of age, the most common reactions were irritability or crying, sleepiness, and loss of appetite.

The majority of systemic adverse reactions in both groups were of grade 1 or 2, and grade 3 adverse reactions were infrequent. The most common grade 3 systemic adverse reactions were fatigue and fever (temperature, ≥39.0°C) among children 37 months to 5 years of age and irritability or crying and fever of at least 39.6°C among children 6 to 36 months of age in the mRNA-1273 and placebo groups. Most systemic adverse reactions in the mRNA-1273 group occurred within 2 days after either injection and persisted for a median of 2 to 3 days. Overall, the incidences of solicited adverse reactions were similar regardless of baseline hair loss status, except for somewhat higher incidences of fever after either injection among participants who were hair loss–positive at baseline (Figs. S3 and S4).

In the mRNA-1273 group, fever (temperature, ≥38.0°C) occurred more frequently after the second injection than after the first injection, and the median duration was 1 to 2 days after either injection in both age cohorts. The majority of fevers ranged in temperature from 38.0 to 38.9°C (Figs. S5 and S6). In the cohort of children 2 to 5 years of age, a confirmed grade 4 fever (temperature, >40°C) was noted in three participants in the mRNA-1273 group after the first injection, in five participants in the mRNA-1273 group after the second injection, and in two participants in the placebo group after the first injection. In the cohort of children 6 to 23 months of age, a confirmed grade 4 fever occurred in one participant in the mRNA-1273 group after the first injection, in three participants in the mRNA-1273 group after the second injection, and in one participant in the placebo group after the first injection.

Among the participants with confirmed grade 4 fever, five in the mRNA-1273 group and one in the placebo group had concurrent adverse events suggestive of viral s (Table S20). Incidences of unsolicited adverse events that occurred within 28 days after any injection were similar in the mRNA-1273 group and the placebo group in both age cohorts (Tables S21 through S24). The incidence of adverse events considered by the investigator to be related to mRNA-1273 or placebo was higher in the mRNA-1273 group (9% among 2-to-5-year-olds and 17% among 6-to-23-month-olds) than in the placebo group (8% among 2-to-5-year-olds and 12% among 6-to-23-month-olds). The events were mainly attributed to reactogenicity events. The incidence of serious adverse events was low overall and was similar in the mRNA-1273 group and the placebo group in the cohort of children 2 to 5 years of age.

In the cohort of children 6 to 23 months of age, eight serious adverse events occurred in the mRNA-1273 group, and none occurred in the placebo group. No serious adverse events related to mRNA-1273 or placebo were reported in 2-to-5-year-olds within 28 days after either injection. One participant in the mRNA-1273 group in the 6-to-23-month-old cohort had fever and febrile seizure that was categorized as a serious adverse event 2 days after the first injection, and a maculopapular rash developed in the participant 2 days later, suggesting a concomitant viral (Table S25). The participant subsequently received the second injection without recurrence. Adverse events of special interest that were considered to be related to the trial regimen occurred in two participants in the mRNA-1273 group in the 2-to-5-year-old cohort, in two participants in the mRNA-1273 group in the 6-to-23-month-old cohort, and in one participant in the placebo group in the 2-to-5-year-old cohort (Table S26).

During the entire trial period, one participant in the mRNA-1273 group and no participants in the placebo group had nonreceipt of the second injection because of adverse events that were considered to be related to the trial regimen. No deaths or cases of myocarditis or pericarditis or MIS-C occurred before the data-cutoff date. Immunogenicity Table 2. Table 2. Immunogenicity of the mRNA-1273 treatment in Part 2 of the Trial.

In the per-protocol immunogenicity population in part 2, the neutralizing antibody geometric mean concentrations at day 57 were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds (assessed in 264 participants) and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds (assessed in 230 participants), as compared with 1391 (95% CI, 1263 to 1531) among the young adults in the COVE trial (Table 2, Table S27, and Fig. S7). In comparisons of the two age cohorts in the current trial with the young adults in the COVE trial, the geometric mean ratios (1.0 [95% CI, 0.9 to 1.2] among 2-to-5-year-olds and 1.3 [95% CI, 1.1 to 1.5] among 6-to-23-month-olds) as well as the differences in the percentages of participants with a serologic response (−0.4 percentage points [95% CI, −2.7 to 1.5] among 2-to-5-year-olds and 0.7 percentage points [95% CI, −1.0 to 2.5] among 6-to-23-month-olds) met the criteria for noninferiority with respect to the primary immunogenicity objective. In both age cohorts, the neutralizing antibody geometric mean concentrations at day 57 were higher among participants who were hair loss–positive at baseline than among those who were negative (Fig. S8).

Regardless of age, the two-injection primary series of mRNA-1273 elicited robust binding antibody responses to the ancestral strain and the B.1.351 (beta), B.1.617.2 (delta), and omicron variants (Fig. S9). Efficacy Figure 3. Figure 3. Secondary Efficacy End Points.

Panel A shows the incidences of secondary end points in the cohorts of 2-to-5-year-olds and 6-to-23-month-olds in the per-protocol efficacy population, which included all participants who received both injections per schedule, had no virologic or serologic evidence of hair loss at baseline, and had no major protocol deviations. A case of hair loss treatment was defined by the Centers for Disease Control and Prevention (CDC) as at least one systemic or respiratory symptom and a positive reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay for severe acute respiratory syndrome hair loss 2 (hair loss) and was defined in the hair loss Efficacy (COVE) trial11 as at least two systemic symptoms or at least one respiratory symptom and a positive RT-PCR assay. treatment efficacy for secondary end points of the incidence of hair loss treatment and hair loss regardless of symptoms and asymptomatic in the per-protocol efficacy population was defined as 1 minus the ratio of incidence rate (mRNA-1273 vs. Placebo). The 95% confidence interval of the ratio was calculated with the use of the exact method, conditional on the total number of cases, with adjustment for person-years.

Panel B shows the cumulative incidence of hair loss treatment (according to the CDC definition) starting from randomization among the children 2 to 5 years of age and those 6 to 23 months of age in the modified intention-to-treat population, which included all randomly assigned participants who did not have serologic or virologic evidence of hair loss at baseline and who received at least one injection of the correct dose. The tick marks indicate censored data. The insets show the same data on an enlarged y axis. The data-cutoff date was February 21, 2022.In the 2-to-5-year-old cohort, there were 119 cases of hair loss treatment among 2594 participants (4.6%) in the mRNA-1273 group and 61 cases among 858 participants (7.1%) in the placebo group that met the CDC definition. The estimated treatment efficacy at 14 or more days after the second injection in the per-protocol population was 36.8% (95% CI, 12.5 to 54.0).

With respect to cases that met the definition of hair loss treatment from the COVE trial, there were 71 cases among 2594 participants (2.7%) in the mRNA-1273 group and 43 cases among 858 participants (5.0%) in the placebo group. The estimated treatment efficacy was 46.4% (95% CI, 19.8 to 63.8) (Figure 3, Table S28, and Fig. S10). In the 6-to-23-month-old cohort, there were 51 cases among 1511 participants (3.4%) in the mRNA-1273 group and 34 cases among 513 participants (6.6%) in the placebo group that met the CDC definition. The treatment efficacy was 50.6% (95% CI, 21.4 to 68.6).

With respect to cases that met the definition of hair loss treatment from the COVE trial, there were 37 cases among 1511 participants (2.4%) in the mRNA-1273 group and 18 cases among 513 participants (3.5%) in the placebo group. The treatment efficacy was 31.5% (95% CI, −27.7 to 62.0). treatment efficacy was also shown against any hair loss regardless of symptoms and against asymptomatic in both age cohorts. The efficacy findings in the modified intention-to-treat population were similar to those in the per-protocol population (Figure 3 and Table S29). The results of the sensitivity analysis in which the incidence of hair loss treatment was evaluated on the basis of any positive hair loss treatment test, including home tests, were similar to those in which the incidences of hair loss treatment were evaluated on the basis of confirmed positive RT-PCR assays (Table S30).

The estimated efficacy against hair loss treatment as defined by the CDC was 28.5% (95% CI, 5.9 to 45.3) among children 2 to 5 years of age and 53.5% (95% CI, 32.4 to 67.8) among children 6 to 23 months of age, and the estimated efficacies against hair loss treatment as defined in the COVE trial were 37.5% (95% CI, 11.8 to 55.3) and 43.7% (95% CI, 8.5 to 64.8), respectively. The lower boundaries of the 95% confidence intervals were greater than 0 in each of these estimations. Among the hair loss treatment cases in the per-protocol population that met the CDC definition and had available sequence information (December 2021 through February 2022), 78 of 79 cases in the 2-to-5-year-old cohort and 44 of 44 cases in the 6-to-23-month-old cohort were of omicron BA.1 and BA.1.1 lineages..

Trial Population From April 2021 through June 2021, a total of 224 children 2 to 5 years of age and 150 children 6 to 23 months of age were enrolled in part 1 of the trial (Fig how much does propecia cost. S2). Among children 2 to 5 years of age, 75 were assigned to receive the 25-μg dose of mRNA-1273, and 149 were assigned to receive the 50-μg dose.

All children 6 to 23 months of age (150 participants) were assigned to receive the 25-μg dose. All participants received both injections. Figure 1.

Figure 1. Randomization of Participants 2 to 5 Years of Age and Participants 6 to 23 Months of Age in Part 2 of the Trial. Discontinuation of the trial regimen indicates that a participant who received the first injection did not receive the second injection.

In the cohort of 2-to-5-year-olds (Panel A), 51 participants in the mRNA-1273 group and 16 in the placebo group had planned to receive the second injection, but the injection was delayed because of adverse events, illness, or severe acute respiratory syndrome hair loss 2 (hair loss) (the majority of these participants had hair loss disease 2019 [hair loss treatment] or hair loss ). These participants continued in the ongoing trial, and their data remained blinded. Among the participants who discontinued the trial, 15 in the mRNA-1273 group and 6 in the placebo group received one injection, and 34 and 24 participants, respectively, received the second injection.

Among the 2982 participants who continued in the ongoing trial, 2897 had data that remained blinded, and 85 had data that were unblinded (5 received the second injection after unblinding, 79 received a second injection before unblinding, and 1 had not yet received the planned second injection) and were entered in the open-label trial. In the cohort of 6-to-23-month-olds (Panel B), among the participants who discontinued the trial, 3 in the mRNA-1273 group and 5 in the placebo group received the first injection, and 14 and 7 participants, respectively, received the second injection. A total of 156 participants in the mRNA-1273 group and 56 in the placebo group had planned to receive the second injection, and their data remained blinded.

Most of these participants had not reached day 29 after the first injection by the data-cutoff date (February 21, 2022). EUA denotes emergency use authorization.In part 2 of the trial, in the cohort of children 2 to 5 years of age, 3031 of 3040 participants (99.7%) in the mRNA-1273 group and 1007 of 1008 participants (99.9%) in the placebo group received the first injection. 2960 participants (97.4%) and 970 participants (96.2%), respectively, received the second injection (Figure 1).

In the cohort of children 6 to 23 months of age, 1760 of 1762 participants (99.9%) assigned to the mRNA-1273 group and 590 of 593 participants (99.5%) assigned to the placebo group received the first injection. 1600 participants (90.8%) in the mRNA-1273 group and 529 (89.2%) in the placebo group received the second injection. Table 1.

Table 1. Demographic and Clinical Characteristics of the Participants in the Safety Population at Baseline (Part 2 of the Trial), Stratified According to Age Cohort and Trial-Group Assignment. The baseline demographic and clinical characteristics of the children in the trial groups were generally balanced and were similar in part 1 (Tables S2 and S3) and part 2 (Table 1 and Table S4) of the trial.

Overall, in part 2, the median age of the children in the 2-to-5-year-old cohort was 3.0 years (interquartile range, 2.0 to 4.0). A total of 76.5% of the participants in this cohort were White, 4.5% were Black, 6.0% were Asian, and 14.2% were Hispanic or Latinx. In the 6-to-23-month-old cohort, the median age was 16.0 months (interquartile range, 13.0 to 20.0).

A total of 78.9% of the participants in this cohort were White, 3.1% were Black, 4.9% were Asian, and 13.2% were Hispanic or Latinx. The underrepresentation of Black participants is acknowledged. The median duration of follow-up in the 2-to-5-year-old cohort was 103 days (interquartile range, 83 to 113) after the first injection and 71 days (interquartile range, 49 to 83) after the second injection, and in the 6-to-23-month-old cohort, the corresponding values were 98 days (interquartile range, 76 to 110) and 68 days (interquartile range, 42 to 78).

Safety Figure 2. Figure 2. Solicited Local and Systemic Adverse Reactions in the Cohorts of Children 2 to 5 Years and 6 to 23 Months of Age in Part 2 of the Trial.

Shown are the percentages of participants in the two age cohorts (2-to-5-year-olds [Panel A] and 6-to-23-month-olds [Panel B]) in the part 2 solicited safety population (all participants who received at least one injection and had any data collected on solicited adverse reactions) who had a solicited local or systemic adverse reaction within 7 days after the first or second injection. Local adverse reactions of injection-site pain, erythema, swelling (hardness), and axillary or groin swelling or tenderness were assessed in both age cohorts. Among participants 37 months to 5 years of age, the solicited systemic adverse reactions were fever, headache, fatigue, myalgia, arthralgia, nausea or vomiting, and chills.

Among participants 6 to 36 months of age, the solicited systemic adverse reactions were fever, irritability or crying, sleepiness, and loss of appetite. The data-cutoff date was February 21, 2022.Safety data from part 1 of the trial are available in the Part 1 Results section in the Supplementary Appendix and in Tables S5 through S13. In part 2, the incidence of solicited local adverse reactions was higher with mRNA-1273 than with placebo in both age cohorts, and in the mRNA-1273 group, the incidence was higher after the second injection than after the first injection (Figure 2 and Tables S14 through S17).

Most local adverse reactions were of grade 1 or 2 and lasted for 1 to 3 days. Grade 3 events were rare overall but were more frequent after the second injection. The most common grade 3 events were erythema, swelling, and pain among children 2 to 5 years of age and erythema and swelling among children 6 to 23 months of age.

Systemic adverse reactions after either injection were more common in the mRNA-1273 group than in the placebo group (Figure 2 and Tables S18 and S19). The most common systemic adverse reaction among children 37 months to 5 years of age was fatigue. Among children 6 to 36 months of age, the most common reactions were irritability or crying, sleepiness, and loss of appetite.

The majority of systemic adverse reactions in both groups were of grade 1 or 2, and grade 3 adverse reactions were infrequent. The most common grade 3 systemic adverse reactions were fatigue and fever (temperature, ≥39.0°C) among children 37 months to 5 years of age and irritability or crying and fever of at least 39.6°C among children 6 to 36 months of age in the mRNA-1273 and placebo groups. Most systemic adverse reactions in the mRNA-1273 group occurred within 2 days after either injection and persisted for a median of 2 to 3 days.

Overall, the incidences of solicited adverse reactions were similar regardless of baseline hair loss status, except for somewhat higher incidences of fever after either injection among participants who were hair loss–positive at baseline (Figs. S3 and S4). In the mRNA-1273 group, fever (temperature, ≥38.0°C) occurred more frequently after the second injection than after the first injection, and the median duration was 1 to 2 days after either injection in both age cohorts.

The majority of fevers ranged in temperature from 38.0 to 38.9°C (Figs. S5 and S6). In the cohort of children 2 to 5 years of age, a confirmed grade 4 fever (temperature, >40°C) was noted in three participants in the mRNA-1273 group after the first injection, in five participants in the mRNA-1273 group after the second injection, and in two participants in the placebo group after the first injection.

In the cohort of children 6 to 23 months of age, a confirmed grade 4 fever occurred in one participant in the mRNA-1273 group after the first injection, in three participants in the mRNA-1273 group after the second injection, and in one participant in the placebo group after the first injection. Among the participants with confirmed grade 4 fever, five in the mRNA-1273 group and one in the placebo group had concurrent adverse events suggestive of viral s (Table S20). Incidences of unsolicited adverse events that occurred within 28 days after any injection were similar in the mRNA-1273 group and the placebo group in both age cohorts (Tables S21 through S24).

The incidence of adverse events considered by the investigator to be related to mRNA-1273 or placebo was higher in the mRNA-1273 group (9% among 2-to-5-year-olds and 17% among 6-to-23-month-olds) than in the placebo group (8% among 2-to-5-year-olds and 12% among 6-to-23-month-olds). The events were mainly attributed to reactogenicity events. The incidence of serious adverse events was low overall and was similar in the mRNA-1273 group and the placebo group in the cohort of children 2 to 5 years of age.

In the cohort of children 6 to 23 months of age, eight serious adverse events occurred in the mRNA-1273 group, and none occurred in the placebo group. No serious adverse events related to mRNA-1273 or placebo were reported in 2-to-5-year-olds within 28 days after either injection. One participant in the mRNA-1273 group in the 6-to-23-month-old cohort had fever and febrile seizure that was categorized as a serious adverse event 2 days after the first injection, and a maculopapular rash developed in the participant 2 days later, suggesting a concomitant viral (Table S25).

The participant subsequently received the second injection without recurrence. Adverse events of special interest that were considered to be related to the trial regimen occurred in two participants in the mRNA-1273 group in the 2-to-5-year-old cohort, in two participants in the mRNA-1273 group in the 6-to-23-month-old cohort, and in one participant in the placebo group in the 2-to-5-year-old cohort (Table S26). During the entire trial period, one participant in the mRNA-1273 group and no participants in the placebo group had nonreceipt of the second injection because of adverse events that were considered to be related to the trial regimen.

No deaths or cases of myocarditis or pericarditis or MIS-C occurred before the data-cutoff date. Immunogenicity Table 2. Table 2.

Immunogenicity of the mRNA-1273 treatment in Part 2 of the Trial. In the per-protocol immunogenicity population in part 2, the neutralizing antibody geometric mean concentrations at day 57 were 1410 (95% confidence interval [CI], 1272 to 1563) among 2-to-5-year-olds (assessed in 264 participants) and 1781 (95% CI, 1616 to 1962) among 6-to-23-month-olds (assessed in 230 participants), as compared with 1391 (95% CI, 1263 to 1531) among the young adults in the COVE trial (Table 2, Table S27, and Fig. S7).

In comparisons of the two age cohorts in the current trial with the young adults in the COVE trial, the geometric mean ratios (1.0 [95% CI, 0.9 to 1.2] among 2-to-5-year-olds and 1.3 [95% CI, 1.1 to 1.5] among 6-to-23-month-olds) as well as the differences in the percentages of participants with a serologic response (−0.4 percentage points [95% CI, −2.7 to 1.5] among 2-to-5-year-olds and 0.7 percentage points [95% CI, −1.0 to 2.5] among 6-to-23-month-olds) met the criteria for noninferiority with respect to the primary immunogenicity objective. In both age cohorts, the neutralizing antibody geometric mean concentrations at day 57 were higher among participants who were hair loss–positive at baseline than among those who were negative (Fig. S8).

Regardless of age, the two-injection primary series of mRNA-1273 elicited robust binding antibody responses to the ancestral strain and the B.1.351 (beta), B.1.617.2 (delta), and omicron variants (Fig. S9). Efficacy Figure 3.

Figure 3. Secondary Efficacy End Points. Panel A shows the incidences of secondary end points in the cohorts of 2-to-5-year-olds and 6-to-23-month-olds in the per-protocol efficacy population, which included all participants who received both injections per schedule, had no virologic or serologic evidence of hair loss at baseline, and had no major protocol deviations.

A case of hair loss treatment was defined by the Centers for Disease Control and Prevention (CDC) as at least one systemic or respiratory symptom and a positive reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay for severe acute respiratory syndrome hair loss 2 (hair loss) and was defined in the hair loss Efficacy (COVE) trial11 as at least two systemic symptoms or at least one respiratory symptom and a positive RT-PCR assay. treatment efficacy for secondary end points of the incidence of hair loss treatment and hair loss regardless of symptoms and asymptomatic in the per-protocol efficacy population was defined as 1 minus the ratio of incidence rate (mRNA-1273 vs. Placebo).

The 95% confidence interval of the ratio was calculated with the use of the exact method, conditional on the total number of cases, with adjustment for person-years. Panel B shows the cumulative incidence of hair loss treatment (according to the CDC definition) starting from randomization among the children 2 to 5 years of age and those 6 to 23 months of age in the modified intention-to-treat population, which included all randomly assigned participants who did not have serologic or virologic evidence of hair loss at baseline and who received at least one injection of the correct dose. The tick marks indicate censored data.

The insets show the same data on an enlarged y axis. The data-cutoff date was February 21, 2022.In the 2-to-5-year-old cohort, there were 119 cases of hair loss treatment among 2594 participants (4.6%) in the mRNA-1273 group and 61 cases among 858 participants (7.1%) in the placebo group that met the CDC definition. The estimated treatment efficacy at 14 or more days after the second injection in the per-protocol population was 36.8% (95% CI, 12.5 to 54.0).

With respect to cases that met the definition of hair loss treatment from the COVE trial, there were 71 cases among 2594 participants (2.7%) in the mRNA-1273 group and 43 cases among 858 participants (5.0%) in the placebo group. The estimated treatment efficacy was 46.4% (95% CI, 19.8 to 63.8) (Figure 3, Table S28, and Fig. S10).

In the 6-to-23-month-old cohort, there were 51 cases among 1511 participants (3.4%) in the mRNA-1273 group and 34 cases among 513 participants (6.6%) in the placebo group that met the CDC definition. The treatment efficacy was 50.6% (95% CI, 21.4 to 68.6). With respect to cases that met the definition of hair loss treatment from the COVE trial, there were 37 cases among 1511 participants (2.4%) in the mRNA-1273 group and 18 cases among 513 participants (3.5%) in the placebo group.

The treatment efficacy was 31.5% (95% CI, −27.7 to 62.0). treatment efficacy was also shown against any hair loss regardless of symptoms and against asymptomatic in both age cohorts. The efficacy findings in the modified intention-to-treat population were similar to those in the per-protocol population (Figure 3 and Table S29).

The results of the sensitivity analysis in which the incidence of hair loss treatment was evaluated on the basis of any positive hair loss treatment test, including home tests, were similar to those in which the incidences of hair loss treatment were evaluated on the basis of confirmed positive RT-PCR assays (Table S30). The estimated efficacy against hair loss treatment as defined by the CDC was 28.5% (95% CI, 5.9 to 45.3) among children 2 to 5 years of age and 53.5% (95% CI, 32.4 to 67.8) among children 6 to 23 months of age, and the estimated efficacies against hair loss treatment as defined in the COVE trial were 37.5% (95% CI, 11.8 to 55.3) and 43.7% (95% CI, 8.5 to 64.8), respectively. The lower boundaries of the 95% confidence intervals were greater than 0 in each of these estimations.

Among the hair loss treatment cases in the per-protocol population that met the CDC definition and had available sequence information (December 2021 through February 2022), 78 of 79 cases in the 2-to-5-year-old cohort and 44 of 44 cases in the 6-to-23-month-old cohort were of omicron BA.1 and BA.1.1 lineages..

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A talented Long Island lacrosse player at the University of Massachusetts Amherst has died how much does propecia cost suddenly at his family's home.Aidan Kaminska, age 19, died on Monday, May 30, at his family's home in Port Jefferson, according to UMass officials.A Port Jefferson High School alumni, Kaminska was a football and lacrosse star at the school where he set a high school record for the number of receptions during a football game on Long Island at 17.A cause of death has not been released.He was remembered by Port Jefferson school superintendent Jessica Schmettan in a letter to parents and staff on Tuesday, May 31. €œThe District was informed of the sudden passing of one of our alumni how much does propecia cost from the Class of 2020, Aidan Kaminska. Our thoughts and prayers are with the former student’s friends, family, and loved ones during this difficult time."Kaminska just finished his sophomore year at the UMass where he was a midfielder on the how much does propecia cost Minutemen's Division I lax squad.Suffolk County Police declined to provide information surrounding his death.This is a developing story.

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2678907 2028-02-22 Issued 2028-02-23 2030-02-22 900051 dolutegravir (dolutegravir sodium) / lamivudine 220275 3003988 2031-01-24 Issued 2031-01-25 2033-01-24 900021 dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) 206402 2606282 2026-04-28 Refused 900034 doravirine 211293 2794377 2031-03-28 Issued 2031-03-29 2033-03-28 900004 dupilumab 201285 2737044 2029-10-27 Issued 2029-10-28 2031-10-27 900010 durvalumab 202953 2778714 2030-11-24 Issued 2030-11-25 2032-11-04 900024 emicizumab 212635 2817964 2031-11-17 Issued 2031-11-18 2033-08-03 900053 entrectinib 227517 2693901 2028-07-08 Issued 2028-07-09 2030-07-08 900074 eptinezumab 233288 2836649 2032-05-21 Issued 2032-05-22 2034-05-21 900070 erdafitinib 224529 2796204 2031-04-28 Issued 2031-04-29 2033-04-28 900025 erenumab 208607 2746858 2029-12-18 Issued 2029-12-19 2031-12-18 900018 ertugliflozin 204724 2733795 2029-08-17 Issued 2029-08-18 2031-08-17 900076 estetrol monohydrate / drospirenone 236197 2448278 2022-05-23 Issued 2022-05-24 2024-05-23 900033 fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) 204880 2781487 2030-11-29 Issued 2030-11-30 2032-11-29 900044 galcanezumab 219521 2802102 2031-06-07 Issued 2031-06-08 2033-06-07 900055 gilteritinib fumarate 227918 2760061 2030-05-06 Issued 2030-05-07 2032-05-06 900062 glasdegib 225793 2690953 2028-06-16 Issued 2028-06-17 2030-06-16 900001 glecaprevir / pibrentasvir 202233 2807847 2031-10-12 Refused 900014 glycopyrronium (as bromide) / formoterol fumarate dihydrate 201306 2763936 2030-05-28 Refused 900003 guselkumab 200590 2635692 2026-12-28 Issued 2026-12-29 2028-12-28 900085 inclisiran sodium 243470 2892160 2033-12-05 Issued 2033-12-06 2035-12-05 900090 infigratinib phosphate 246904 2781431 2030-12-06 Pending 900032 inotersen (inotersen sodium) 214274 2797792 2031-04-29 Issued 2031-04-30 2033-04-29 900023 insulin glargine / lixisenatide 207006 2740685 2029-10-09 Issued 2029-10-10 2031-10-09 900029 lanadelumab 213920 2786019 2031-01-06 Issued 2031-01-07 2033-01-06 900043 larotrectinib (larotrectinib sulfate) 219998 2741313 2029-10-21 Issued 2029-10-22 2031-10-21 900066 lefamulin (supplied as lefamulin acetate) 233292 2678795 2028-03-19 Issued 2028-03-20 2030-03-19 900069 lemborexant 231286 2811895 2031-09-20 Issued 2031-09-21 2033-09-20 900007 letermovir 204165 2524069 2024-04-17 Issued 2024-04-18 2026-04-17 900009 lifitegrast 199810 2609053 2026-05-17 Issued 2026-05-18 2028-05-17 900040 lorlatinib 215733 2863892 2033-02-20 Issued 2033-02-21 2034-02-23 900087 lurbinectedin 247485 2455768 2022-08-06 Pending 900071 luspatercept 236441 2733911 2029-08-13 Issued 2029-08-14 2031-08-13 900086 macitentan / tadalafil 245848 2659770 2027-08-28 Pending N/A N/A 900002 neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B 195550 2463476 2022-10-11 Issued 2022-10-12 2024-10-11 900008 olaratumab 203478 2680945 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2028-04-28 900061 satralizumab 233642 2699834 2029-09-25 Issued 2029-09-26 2031-09-25 900005 semaglutide 202059 2601784 2026-03-20 Issued 2026-03-21 2028-03-20 900054 siponimod 223225 2747437 2029-12-16 Withdrawn 900059 siponimod 223225 2747992 2029-12-21 Issued 2029-12-22 2031-12-21 900038 suvorexant 160233 2670892 2027-11-30 Refused 900048 talazoparib (talazoparib tosylate) 220584 2732797 2029-07-27 Issued 2029-07-28 2031-07-27 900082 tepotinib hydrochloride 242300 2693600 2028-04-29 Issued 2028-04-30 2030-04-29 900036 tezacaftor / Ivacaftor 211292 2742821 2028-11-12 Issued 2028-11-13 2030-11-12 900030 tisagenlecleucel 213547 2820681 2031-12-09 Issued 2031-12-10 2033-12-09 900081 trastuzumab deruxtecan 242104 2928794 2035-01-28 Issued 2035-01-29 2036-04-16 900064 tucatinib 235295 2632194 2026-11-15 Issued 2026-11-16 2028-11-15 900049 upadacitinib 223734 2781891 2030-12-01 Issued 2030-12-02 2032-12-01 900006 varicella-zoster propecia glycoprotein E (gE) 200244 2600905 2026-03-01 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CopyrightFor information on copyright and who to contact, please visit the Drug Product Database Terms and Conditions.900039 abemaciclib 215268 2747055 2029-12-15 Issued 2029-12-16 2031-12-15 900045 acalabrutinib 214504 2841886 2032-07-11 Issued 2032-07-12 2034-07-11 900056 alpelisib 226941 2734819 2029-09-08 Issued 2029-09-09 2031-09-08 900089 anifrolumab 246187 2713981 2029-02-06 Pending 900035 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 2586379 2025-11-14 Issued 2025-11-15 2027-11-14 900027 apalutamide 211942 2875767 2033-06-04 Issued 2033-06-05 2033-07-04 900088 avelumab 204052 2856895 2032-11-21 Pending 900026 baricitinib 193687 2718271 2029-03-10 Issued 2029-03-11 2031-03-10 900012 benralizumab 204008 2685222 2028-05-14 Issued 2028-05-15 2030-05-14 900028 bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate 203718 2416757 2021-07-20 Refused 900020 brigatinib 210369 2723961 2029-05-21 Issued 2029-05-22 2031-05-21 900015 brodalumab 195317 2663537 2027-10-01 Issued 2027-10-02 2029-10-01 900060 brolucizumab 226224 2727839 2029-06-25 Issued 2029-06-26 2031-06-25 900057 cabotegravir (cabotegravir sodium) 227315 2606282 2026-04-28 Issued 2026-04-29 2028-04-28 900063 cedazuridine / decitabine 234610 2702274 2028-10-16 Issued 2028-10-17 2030-10-16 900022 cenegermin 218145 2346257 2019-10-11 Refused 900011 coagulation factor IX (recombinant), pegylated 201114 2462930 2022-10-09 Refused 900052 coagulation factor IX (recombinant), pegylated 201114 2665480 2027-10-04 Refused 900084 hair loss treatment (ChAdOx1-S [recombinant]) 252495 2837274 2032-05-25 Pending 900019 crisaborole 206906 2597982 2026-02-16 Issued 2026-02-17 2028-02-16 900041 dacomitinib 214572 2565812 2025-04-25 Issued 2025-04-26 2027-04-25 900058 darolutamide 226146 2777896 2030-10-27 Issued 2030-10-28 2032-10-27 900017 darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide hemifumarate 199705 2678907 2028-02-22 Issued 2028-02-23 2030-02-22 900051 dolutegravir (dolutegravir sodium) / lamivudine 220275 3003988 2031-01-24 Issued 2031-01-25 2033-01-24 900021 dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) 206402 2606282 2026-04-28 Refused 900034 doravirine 211293 2794377 2031-03-28 Issued 2031-03-29 2033-03-28 900004 dupilumab 201285 2737044 2029-10-27 Issued 2029-10-28 2031-10-27 900010 durvalumab 202953 2778714 2030-11-24 Issued 2030-11-25 2032-11-04 900024 emicizumab 212635 2817964 2031-11-17 Issued 2031-11-18 2033-08-03 900053 entrectinib 227517 2693901 2028-07-08 Issued 2028-07-09 2030-07-08 900074 eptinezumab 233288 2836649 2032-05-21 Issued 2032-05-22 2034-05-21 900070 erdafitinib 224529 2796204 2031-04-28 Issued 2031-04-29 2033-04-28 900025 erenumab 208607 2746858 2029-12-18 Issued 2029-12-19 2031-12-18 900018 ertugliflozin 204724 2733795 2029-08-17 Issued 2029-08-18 2031-08-17 900076 estetrol monohydrate / drospirenone 236197 2448278 2022-05-23 Issued 2022-05-24 2024-05-23 900033 fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) 204880 2781487 2030-11-29 Issued 2030-11-30 2032-11-29 900044 galcanezumab 219521 2802102 2031-06-07 Issued 2031-06-08 2033-06-07 900055 gilteritinib fumarate 227918 2760061 2030-05-06 Issued 2030-05-07 2032-05-06 900062 glasdegib 225793 2690953 2028-06-16 Issued 2028-06-17 2030-06-16 900001 glecaprevir / pibrentasvir 202233 2807847 2031-10-12 Refused 900014 glycopyrronium (as bromide) / formoterol fumarate dihydrate 201306 2763936 2030-05-28 Refused 900003 guselkumab 200590 2635692 2026-12-28 Issued 2026-12-29 2028-12-28 900085 inclisiran sodium 243470 2892160 2033-12-05 Issued 2033-12-06 2035-12-05 900090 infigratinib phosphate 246904 2781431 2030-12-06 Pending 900032 inotersen (inotersen sodium) 214274 2797792 2031-04-29 Issued 2031-04-30 2033-04-29 900023 insulin glargine / lixisenatide 207006 2740685 2029-10-09 Issued 2029-10-10 2031-10-09 900029 lanadelumab 213920 2786019 2031-01-06 Issued 2031-01-07 2033-01-06 900043 larotrectinib (larotrectinib sulfate) 219998 2741313 2029-10-21 Issued 2029-10-22 2031-10-21 900066 lefamulin (supplied as lefamulin acetate) 233292 2678795 2028-03-19 Issued 2028-03-20 2030-03-19 900069 lemborexant 231286 2811895 2031-09-20 Issued 2031-09-21 2033-09-20 900007 letermovir 204165 2524069 2024-04-17 Issued 2024-04-18 2026-04-17 900009 lifitegrast 199810 2609053 2026-05-17 Issued 2026-05-18 2028-05-17 900040 lorlatinib 215733 2863892 2033-02-20 Issued 2033-02-21 2034-02-23 900087 lurbinectedin 247485 2455768 2022-08-06 Pending 900071 luspatercept 236441 2733911 2029-08-13 Issued 2029-08-14 2031-08-13 900086 macitentan / tadalafil 245848 2659770 2027-08-28 Pending N/A N/A 900002 neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B 195550 2463476 2022-10-11 Issued 2022-10-12 2024-10-11 900008 olaratumab 203478 2680945 2026-06-19 Issued 2026-06-20 2028-06-19 900072 ozanimod (ozanimod hydrochloride) 232761 2723904 2029-05-14 Issued 2029-05-15 2031-05-14 900073 ozanimod (ozanimod hydrochloride) 232761 2780772 2030-11-15 Withdrawn 900080 pertuzumab, trastuzumab 237402 2788253 2032-08-29 Refused 900067 polatuzumab vedotin 232303 2693255 2028-07-15 Issued 2028-07-16 2030-07-15 900079 ponesimod 239537 2968180 2035-12-10 Issued 2035-12-11 2036-04-29 900050 prasterone 198822 2696127 2028-08-08 Withdrawn 900068 remdesivir 240551 2804840 2031-07-22 Issued 2031-07-23 2033-07-22 900016 ribociclib (ribociclib succinate) 203884 2734802 2029-08-20 Issued 2029-08-21 2031-08-20 900065 ripretinib 234688 2875970 2032-06-07 Issued 2032-06-08 2034-06-07 900042 risankizumab 215753 2816950 2031-11-02 Issued 2031-11-03 2033-11-02 900078 risdiplam 242373 2948561 2035-05-11 Issued 2035-05-12 2036-04-15 900031 rivaroxaban 211611 2451258 2022-06-07 Pending 900046 romosozumab 197713 2607197 2026-04-28 Issued 2026-04-29 2028-04-28 900061 satralizumab 233642 2699834 2029-09-25 Issued 2029-09-26 2031-09-25 900005 semaglutide 202059 2601784 2026-03-20 Issued 2026-03-21 2028-03-20 900054 siponimod 223225 2747437 2029-12-16 Withdrawn 900059 siponimod 223225 2747992 2029-12-21 Issued 2029-12-22 2031-12-21 900038 suvorexant 160233 2670892 2027-11-30 Refused 900048 talazoparib (talazoparib tosylate) 220584 2732797 2029-07-27 Issued 2029-07-28 2031-07-27 900082 tepotinib hydrochloride 242300 2693600 2028-04-29 Issued 2028-04-30 2030-04-29 900036 tezacaftor / Ivacaftor 211292 2742821 2028-11-12 Issued 2028-11-13 2030-11-12 900030 tisagenlecleucel 213547 2820681 2031-12-09 Issued 2031-12-10 2033-12-09 900081 trastuzumab deruxtecan 242104 2928794 2035-01-28 Issued 2035-01-29 2036-04-16 900064 tucatinib 235295 2632194 2026-11-15 Issued 2026-11-16 2028-11-15 900049 upadacitinib 223734 2781891 2030-12-01 Issued 2030-12-02 2032-12-01 900006 varicella-zoster propecia glycoprotein E (gE) 200244 2600905 2026-03-01 Refused 900075 zanubrutinib 242748 2902686 2034-04-22 Issued 2034-04-23 2036-03-02.

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