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...
FDA issues SSM St. Clare Health Center a 10-observation Form FDA-483 for GMP deficiencies found during an inspection at an outsourcing facility in Fen...
FDA posts a draft guidance entitled Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs (CDP).
Federal Register notices: FDA classifies three devices into Class 2 based on de novo classification requests Saladax Biomedicals MyCare Psychiatry Cl...
