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...
FDA grants Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis.
FDA approves Mercks Keytruda (pembrolizumab) as the first anti‑PD‑1 therapy that can be given both before and after surgery for adults wit...
FDA places a clinical hold on a Rein Therapeutics Phase 2 (RENEW) trial of LTI-03 due to agency requests for additional non-clinical information.
