FDA clears a BD (Becton, Dickinson) 510(k) for its new automated, high-throughput infectious disease molecular diagnostics platform, BD COR.
FDA approves a Medtronic PMA for the Onyx Frontier drug-eluting stent, indicated for treating patients with coronary artery disease.
Pharmatech Associates managing director Stephanie Gaulding discusses the effects of an FDA proposed revision to the medical device Quality System Regu...
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...