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.
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...
FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric patients with relapse...
