BridgeBio Pharma sells for $110 million its priority review voucher that was awarded last year when FDA approved Nulibry (fosdenopterin) for an ultra-...
FDA sends UCB a complete response letter on its BLA for psoriasis-treating bimekizumab, citing deficiencies from a recent preapproval inspection as th...
A just-released, scathing (XXX INSERT XXX)23-page Form FDA-483 cites 10 GMP deficiencies at Sun Pharmaceutical Industries Halol manufacturing facility...
FDA approves an Eli Lilly NDA for Mounjaro (tirzepatide), a once-weekly injection to improve blood sugar control in adults with Type 2 diabetes, as an...
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...