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Federal Register notice: FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.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.
FDA approves a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areat...
FDA extends its review of UCB's psoriasis drug bimekizumab for reasons the company did not disclose.
FDA clears a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector.
