Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.
FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated automated external d...
The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic approvals in 2023.
FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pa...
Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.
FDA clears a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue.
Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.
