FDA issues a complete response letter on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating pati...
FDA approves a UCB BLA for Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis in certain adult patients.
The U.S. government arrests former DePuy Synthes sales representative Matthew Capobianco on eight counts of wire fraud and one count of making false s...
FDA announces additional changes in the way the Office of Regulatory Affairs operates.
FDA approves Bayers Ultravist (iopromide)-300 and Ultravist-370, iodine-based contrast agents for contrast-enhanced mammography.
FibroGen discontinues its ZEPHYRUS-2 Phase 3 trial of pamrevlumab in patients with idiopathic pulmonary fibrosis after topline data from the earlier Z...
Federal Register notice: FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.
ReShape Lifesciences files a PMA supplement for the companys next generation Lap-Band 2.0 for long-term treatment of obesity.
