FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriate laboratory values ...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.
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
FDA clears an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures.
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...
