Hospira recalls one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial.
FDA posts five device classifications that were requested under the agencys de novo program.
The recent omnibus legislation extends a drug company safe harbor to medical device companies on sharing health care economic information, according t...
An FDA update says AstraZenecas Evusheld may not neutralize the new Covid-19 variant XBB.1.5.
FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventing a needed facility...
FDA issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bon...
FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.
FDA launches a digital technology Leadership Modernization Action Plan.