Reps. Eshoo and McCaul introduce bipartisan legislation to strengthen pediatric drug development.
Zydus Pharmaceuticals asks FDA to take multiple actions against BPI Labs unapproved methylene blue injection product.
Bausch & Lomb asks FDA to impose conditions on any ANDAs for a generic form of its macular edema drug Xipere.
Federal Register notice: FDA makes available a final guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Presc...
Merck stops a Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynparza for treating pa...
Federal Register notice: FDA determines for patent term extension purposes the regulatory review period for QED Therapeutics Truseltiq (infigratinib)....
ProPublica and the Pittsburgh Post-Gazette take aim at alleged FDA failures to properly manage a timely response to reports of problems with Philips R...
FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug substances.
