Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semaglutide (Novo Nordisks...
FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous infusion of liquid l...
FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.
Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after incarceration, community...
FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are being manufactured with...
Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...
FDA publishes two guidances relating to the CDRH/CBER Q-submission process.
GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase 3 PIVOT-PO clinical...
