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...
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...
FDA approves Guardant Healths Shield blood test for colon cancer screening in adults 45 years of age and older who are at average risk for the disease...
