United States Food and Drug Administration
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved
FDA okays Novartis’ second IgA nephropathy therapy Vanrafia
Vanrafia, United States Food and Drug Administration, Approved, Novartis, IGA Glomerulonephritis, Proteinuria
Cellares’ cell therapy factory-in-a-box scores coveted advanced manufacturing technology tag from FDA
Cell Therapy, Advanced Manufacturing Technology, United States Food and Drug Administration, Technology, Identifier, Cell Shuttle, production, Cellares, Biologics License Application, Investigational New Drugs
Atsena reels in $150M to advance work on ocular gene therapies
Atsena, Retinoschisis, Juvenile, X-Linked, United States Food and Drug Administration, Dependovirus, Cloning Vectors, Hereditary, Retinal Diseases, Blindness, ATSN-201, ATSN-101
Mass Firings at FDA Spark Concerns Over Agency’s Future
FDA, layoffs, leadership changes, public health, drug regulation, Trump administration
FDA Shakeup: Peter Marks’ Resignation Rattles Biotech Industry
Peter Marks, FDA resignation, biotech stocks, regulatory uncertainty, drug approvals
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
Subcutaneous Keytruda, FDA decision, September 23, 2025, Merck & Co., cancer treatment, PDUFA date
Equillium’s pivotal GvHD study of anti-CD6 antibody comes up short
United States Food and Drug Administration, itolizumab, In complete remission, day, Equillium
FDAs policy, communications staff likely to be among agencys 3,500 staff cuts
Policy, Communication, Staff, United States Food and Drug Administration, CHARGE Syndrome