Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare invol...
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 issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bon...
FDA launches a digital technology Leadership Modernization Action Plan.
FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.
FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventing a needed facility...
