FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.
FDA approves an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narcan) for treating a dr...
Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of its Ozempic and Wegovy in the U.S.
FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum depression.
An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, the second received by...
FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for combination use with standard-of-care chemotherapy (carboplatin ...
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
FDA publishes a draft guidance with questions and answers on promotional communications for some prescription biologics.
