The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug approvals.
A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from overseas factories that ...
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.
Qalitex Laboratories issues an alert to dietary supplement and wellness product sellers on Amazon about a growing overlap between FDAs enforcement and...
An AbbVie Phase 3 (VERONA) clinical trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndro...
Incyte reports the first positive clinical data from studies evaluating a novel, first-in-class targeted monoclonal antibody in patients with mutant c...