[ Price : $8.95]
FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-st...[ Price : $8.95]
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...[ Price : $8.95]
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...[ Price : $8.95]
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.[ Price : $8.95]
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.[ Price : $8.95]
FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...[ Price : $8.95]
FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...