[ Price : $8.95]
An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpin...[ Price : $8.95]
FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for it...[ Price : $8.95]
FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland fo...[ Price : $8.95]
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy...[ Price : $8.95]
PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and ...[ Price : $8.95]
FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certai...[ Price : $8.95]
FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the...[ Price : $8.95]
FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.