Astellas and Seagen file sBLAs with FDA to change Padcev to regular approval and expand its indication.
Federal Register notice: FDA seeks comments on recommendations by the World Health Organization to impose international manufacturing and distributing...
FDA updates its efforts to coordinate the development of standards for regenerative medicine therapies as required by the 21st Century Cures Act.
An FDA advisory committee votes not to recommend approval of BDs Lutonix drug-coated balloon PTA (percutaneous transluminal angioplasty) catheter for ...
Federal Register notice: FDA seeks public comments on an information collection extension associated with its Guidance for Industry and FDA Staff Cla...
Three SheppardMullins attorneys say a recent FTC settlement in a case involving how app users health data is used is a reminder that companies have pr...
CDRHers Timothy Stenzel and Toby Lowe answer questions in a virtual town hall about Covid-19 diagnostic tests.
Federal Register notice: FDA determines that Arbor Pharmaceuticals Nymalize (nimodipine) oral solution was not withdrawn from sale due to safety or ef...