Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exercise capacity in pati...
FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) for treating Hunter s...
FDA warns Chinas Taizhou Jingshang Cosmetics Technology Co. about CGMP violations in its production of finished drugs.
The CDER Office of Prescription Drug Promotion hits Mayne Pharma over a professional presentation on Nextstellis that it says makes false and misleadi...
GSK and iTeos Therapeutics decide to stop the development of belrestotug, an anti-TIGIT monoclonal antibody for treating certain non-small cell lung c...
Former FDA commissioner David Kessler, who is taking one of the new weight loss drugs, calls on FDA to require data to help people come off the drugs ...
FDA clears a Capillary Biomedical 510(k) for its SteadiSet, a wearable infusion set that delivers insulin from a pump to the body for up to three days...
FDA approves GE HealthCares ultrasound imaging agent Optison 9 for use in pediatric patients.
