Bristol Myers Squibb provides two-year results from its POETYK PSO long-term extension trial of deucravacitinib in adult patients with moderate to sev...
Federal Register notice: FDA announces a 6/7 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Bios...
FDA says an appeals court decision in a case involving orphan drug exclusivity is likely to slow research and innovation into drugs for rare diseases.
CBER director Peter Marks says he wants to continue the Operation Warp Speed attention and quick approval process given to Covid-19 vaccines after the...
FDA approves an oral suspension formulation of Mitsubishi Tanabe Pharma Americas Radicava (edaravone) for treating adults with amyotrophic lateral scl...
FDA extends for 90 days the PDUFA review action dates for Amicus BLA and NDA for components of its AT-GAA, intended to treat late-onset Pompe disease....
Ropes & Gray attorneys see increasing cybersecurity expectations for medical device manufacturers in FDA regulations and congressional legislation.
Sanofi and AstraZeneca say additional Phase 3 and Phase 2b trial data continue to demonstrate nirsevimab efficacy against respiratory syncytial virus ...