In two papers published Wednesday in the New England Journal of Medicine, Pfizer touted positive Phase III data for its respiratory syncytial virus (RSV) vaccine candidate, showing high levels of protection for older adults and infants.
Tag Archive for: Priority Review
After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.
Pfizer notched another score in the race for an RSV vaccine Tuesday, as it announced the FDA has accepted the Biologics License Application for its maternal RSV vaccine and granted the candidate priority review.
Biogen’s $1.5 billion bet is in the home stretch. On Monday, the Cambridge biotech, along with partner Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.
GlaxoSmithKline scored a pivotal Priority Review from the FDA for its respiratory syncytial virus (RSV) vaccine candidate for older adults, which will expedite regulatory evaluation of its clinical data.
GSK beat third-quarter earnings forecasts on Wednesday and raised its 2022 estimate for the second time in four months, continuing its strong start as a standalone prescription medicine business since spinning off its consumer health unit.
Ipsen’s fibrodysplasia ossificans progressiva (FOP) odyssey continues as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee postponed its meeting on the NDA for palovarotene capsules.
The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for this indication.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.