Moderna Inc. has made all necessary submissions required by the U.S. Food and Drug Administration for emergency use authorization of the company’s COVID-19 vaccine in adolescents and children.
The U.S. Food and Drug Administration granted approval for the commercialization of Eli Lilly and Company and Incyte Corporation’s Olumiant (baricitinib), setting a precedent for COVID-19 treatments.
Current COVID-19 booster shots have a problem: they last only about four months and appear to have limited efficacy in a vaccinated population. Clearly, a more durable, more efficacious vaccine is needed, but what should it be? The scientific community has not reached a consensus, according to BioSpace.
Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.
The Janssen COVID-19 vaccine is now limited to certain individuals ages 18 and up after the U.S. Food and Drug Administration downgraded its emergency use authorization.
The U.S. Food and Drug Administration indirectly refuted Pfizer’s recommendation that it’s all right for COVID-19 patients to take another round of Paxlovid if they experience a rebound after completing the first course.
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.
Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
The U.S. Food and Drug Administration approved Phathom Pharmaceuticals Inc.’s Voquezna Triple Pak (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and Voquezna Dual Pak (vonoprazan tablets, amoxicillin capsules) for the treatment of Helicobacter pylori infection in adults.
