FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.
FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...
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.
