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 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.
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.
A look at U.S. Food and Drug Administration PDUFA dates for end-of-August and early-September 2020.
Clinical-stage biopharmaceutical company Zosano Pharma Corporation announced a partnership with EVERSANA, a leading provider of commercial services to the life science industry, to commercialize and distribute Qtrypta in the United States.
Results of a pivotal phase III study of Supernus Pharmaceuticals’ SPN-812 (viloxazine extended-release capsules) were published in the journal Clinical Therapeutics.
The U.S. Food and Drug Administration accepted the filing of Aurinia Pharmaceuticals Inc.’s New Drug Application (NDA) for voclosporin as a potential treatment for lupus nephritis, a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
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).
A look at the U.S. Food and Drug Administration’s drug approval review calendar.