FDA tells Applied Therapeutics its govorestat is on track for the 11/28 PDUFA action date and will not need to go before an advisory committee.
Smiths Medical recalls (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect.
FDA approves AstraZenecas Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis.
Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biological Products into ...
FDA publishes a guidance on the conduct of clinical trials with decentralized elements.
FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.
FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.
PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading partners may not be rea...
