New Bloomberg reporting that FDA is facing mounting internal strain and external criticism just over a year into commissioner Marty Makarys tenure.
Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.
FDA cites multiple manufacturing and quality control deficiencies at a facility operated by Allergan Pharmaceuticals in Ireland following an inspectio...
FDA plans a 6/4 town hall meeting aimed at guiding drug developers through the process of preparing BLAs for cell and gene therapy products. The CBER ...
PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations...
FDA authorizes an expanded access program for an experimental pancreatic cancer therapy from Revolution Medicines, allowing certain patients to receiv...
FDA has approved Arvinas Operations Veppanu (vepdegestrant) for treating certain patients with advanced breast cancer, marking the first authorization...
FDA releases the form FDA-483 with three observations from an inspection at Indias Eugia Pharma Specialties Limited.
