FDA publishes a guidance on the conduct of clinical trials with decentralized elements.
FDA warns Joliet, IL-based TJA Health about CGMP violations in its manufacturing of finished drugs.
FDA warns Fort Worth, TX-based Quality CDMO that it is marketing five unapproved new drugs.
PhRMA asks FDA to consider a phased approach to enforcing the Drug Supply Chain Security Act because many drug company trading partners may not be rea...
FDA approves an expanded use for Novartis Kisqali (ribociclib) combination use with an aromatase inhibitor for the adjuvant treatment of certain peop...
FDA lifts a partial clinical hold against Vigil Neuroscience and its ongoing Phase 1 clinical trial of VG-3927, a small molecule targeting human trigg...
In an untitled letter, FDA says Milan, Italy-based Industria Farmaceutica is manufacturing drugs with CGMP violations.
Medexus Pharmaceuticals says FDA has extended the review of its Medac licensors resubmitted NDA for treosulfan and its use in allogeneic hematopoietic...
