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...
Nipro recalls its MedicaLyte liquid bicarbonate concentrate after confirming bacterial and fungal contamination in returned products.
FDA delays a review decision on a KalVista Pharmaceuticals NDA for sebetralstat, indicated for treating hereditary angioedema.
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.
FDA posts a final guidance entitled ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.
