FDA asks for stakeholder responses to six discussion questions in a paper on regulating generative AI-enabled medical devices.
FDA warns Chinas Tianjin Kilo Pharmaceutical Sci-tech Co. about CGMP deviations the agency found in records it requested on the companys manufacturing...
Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide.
McGuireWoods partner Clint Narver announces his departure from the law practice to rejoin FDA as director of the Office of Compounding Quality and Com...
Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and misleading statements...
FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted through the ANDA pathway ...
While Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended the revocation of the ...
Regeneron Pharmaceuticals stops a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with noninfectious uveit...
