FDA expands the time the Trevo clot retrieval device can be used in stroke patients.
FDA authorizes marketing of the Banyan Brain Trauma Indicator, a blood test that predicts when concussion patients do or do not have intracranial lesi...
FDA accepts for review an Agios Pharmaceuticals NDA for ivosidenib (AG-120) for treating patients with relapsed or refractory acute myeloid leukemia w...
FDA grants Abiomed expanded PMA approval for the Impella 2.5 and Impella CP heart pumps and their use during elective and urgent high risk percutaneou...
Apace Packaging recalls one lot of shingles therapy acyclovir tablets, USP, 400mg, due to a product mix-up.
Federal Register proposed rule: FDA proposes to amend its postmarketing safety reporting regulations for approved new animal drugs to require that cer...
FDA says a petition seeking approval of a generic form of Syprine is moot because the agency has approved an ANDA for the drug.
Stakeholders give FDA a long list of regulations they believe could be modified or eliminated to reduce administrative burden and promote efficiency.