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.
Federal Register notice: FDA renews its Pharmacy Compounding Advisory Committee for an additional two years.
Federal Register notice: FDA withdraws approval of 23 ANDAs from multiple applicants after they notified the agency that the products are no longer be...
