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 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.
