On a CDER guidance recap podcast, master mathematical statistician James Travis explains a new draft guidance on using Bayesian methodology in drug an...
FDA meeting minutes say agency representatives in the 2/26 PDUFA 8 reauthorization discussion agreed to consider a proposal from industry representati...
FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device v...
FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of charting a clear path f...
Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single...
Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 An...
FDA releases the form FDA-483 issued following an inspection at the Micro Labs drug manufacturing facility in Bengaluru, Karnataka, India.
FDA approves Corcept Therapeuticss cortisol-modulating drug Lifyorli (relacorilant) in combination with nab-paclitaxel for patients with platinum-resi...
