A panel of outside advisers to the U.S. Food and Drug Administration voted that a potential Alzheimer’s treatment from Biogen Inc. has not been proven to slow progression of the disease, a sharp rebuke to agency staff who had praised the drug.
Pfizer indicated that the company’s Phase III clinical trial of 44,000 volunteers with partner BioNTech needed less than 2,000 people to be fully enrolled.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention presented details about Covid-19 and the requirements for a vaccine in a nine-hour virtual meeting.
Shares of Alkermes were up in trading after the Ireland-based company announced the experimental schizophrenia drug ALKS 3831 was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.
The U.S.Food and Drug Administration issued a Complete Response Letter for Mesoblast’s Biologics License Application for Ryoncil (remestemcel-L).
The U.S. Food and Drug Administration is wrapping up the month of September with a few PDUFA dates, including an approval review of Aquestive’s Libervant for the management of seizure clusters in epilepsy.
A physician who heads the influential U.S. Food and Drug Administration vaccine advisory committee recused herself from the panel’s review of Covid-19 vaccines because of her role overseeing a clinical trial for Moderna Inc.’s candidate, her spokeswoman told Reuters.
Shares of Reata Pharmaceuticals plunged more than 33 percent after the company announced a potential delay in plans to seek approval of omaveloxolone, an investigational treatment of Friedreich’s ataxia (FA).
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for Mallinckrodt’s investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).
Akcea Therapeutics Inc. announced that the U.S. Food and Drug Administration’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra (volanesorsen) for the treatment of people with familial chylomicronemia syndrome.