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Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biological Products into ...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...
FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treatment of certain peop...
