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.
FDA grants Elixir Medical a breakthrough device designation for its DynamX Sirolimus-Eluting Coronary Bioadaptor System for use in treating coronary a...
A January inspection of Brassica Pharmas Indian sterile drug manufacturing facility leads to a 10-observation Form FDA-483 that cites significant GMP ...
