FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.
Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administration to reschedule t...
FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly diagnosed adult pati...
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...
