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...
Incyte reports the first positive clinical data from studies evaluating a novel, first-in-class targeted monoclonal antibody in patients with mutant c...
FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.
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...
