United States Food and Drug Administration
Annexon Advances Guillain-Barré Syndrome Awareness and Introduces Groundbreaking Targeted Therapy
Guillain-Barré Syndrome (GBS) , Annexon , Tanruprubart (ANX005) , Targeted therapy , GBS education campaign , Move GBS Forward™ , Phase 3 trial results , FDA approval
Former CBER head Peter Marks says he blocked RFK Jr. from vaccine safety database before leaving FDA: AP
Vaccines, Massive, Vaccine Safety, Kennedy, United States Food and Drug Administration, RFK Jr., Disease Outbreaks, Peter Marks, VAERS, Kennedy ‘s
: BMS’ Opdivo plus Yervoy snags FDA nod as first-line treatment for certain colorectal cancer patients
United States Food and Drug Administration, Approved, Burning Mouth Syndrome, Colorectal Carcinoma, Yervoy, first-line, Combined
Novavaxs held-up approval package may signal warning for Covid vaccine makers
Vaccines, Approved, COVID19 (disease), United States Food and Drug Administration, Market, Novavax ‘s, Maker (occupation), Deferred
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