Clene says it plans to submit an NDA in the third quarter for its experimental amyotrophic lateral sclerosis therapy.
The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone.
An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...
FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra.
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PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that overly narrow definitions and unclear expectations...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...
