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...
AstraZeneca says data from its Phase 3 AMPLIFY trial showed that Calquence (acalabrutinib) in combination with venetoclax showed favorable progression...
FDA cites a Kaleo social media post about Auvi-Q (epinephrine injection) because it presented benefit information but failed to include any risk infor...
FDA issues Carie Boyd Pharmaceuticals a six-observation Form FDA-483 after inspecting the firms Irving,TX outsourcing facility last month.
FDA approves an Alpha Cognition NDA for ZUNVEYL (benzgalantamine) for treating mild-to-moderate Alzheimers disease.
