A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from overseas factories that ...
FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental devices.
Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchen...
FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.
FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastatic castration-resista...
Roche moves prasinezumab into a Phase 3 trial after two mid‑stage trials and their open‑label extensions hinted at a disease‑slowing...
Milestone Pharmaceuticals submits its response to a March-issued FDA complete response letter on the companys NDA for irregular heart beat drug Cardam...
Zyno Medical recalls certain Z-800 infusion pumps because they were released to customers with incorrect software versions.
