FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.
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...
Dr. Reddys Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency.
FDA approves Utility Therapeutics Pivya for some uncomplicated urinary tract infections.
Boehringer Ingelheim suggests several modifications to an FDA draft guidance on key information and facilitating understanding in informed consent.
