FDA accepts for priority review a Pfizer NDA for talazoparib for use in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locall...
FDA grants Ironwood Pharmaceuticals an orphan drug designation for olinciguat (IW-1701) for treating patients with sickle cell disease.
FDA issues a guidance on circumstances in which an NDA applicant may be eligible for a barrier-to-innovation PDUFA waiver for fixed-combination and si...
FDA issues a draft guidance updating mechanisms available to submitters to request agency feedback or a meeting on a variety of medical device applica...
Federal Register notice: FDA announces a 7/25 Pulmonary-Allergy Drugs Advisory Committee meeting.
CBER says Tiger Medical is selling the Alere HIV combo test kit without ensuring that restrictions that are part of the kits approval are applied.
FDA releases the FDA-483 issued following an inspection at Indias Glenmark Pharmaceuticals.
FDA approves a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation.