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...
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...
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...
