Mitka M. Oversight of fast-track drug approval by FDA stuck in low gear, critics say. JAMA : the journal of the American Medical Association. 2010;304:1773-5.Mitka M. Oversight of fast-track drug approval by FDA stuck in low gear, critics say. JAMA. 2010;304(16):1773–5. View ...
FDA fast-tracks approval for Alzheimer's drugThe Food and Drug Administration approved a new Alzheimer's drug called Leqembi, that has been shown to slow the decline in memory and thinking. The medication costs more than $26,000 per year.Jan 7, 2023...
Since the US Food and Drug Administration (FDA) established its accelerated drug approval pathway 28 years ago, more than 2 in 5 drugs granted fast-track approval have not been confirmed clinically effective as required, an in-depth investigation published online today inTheBMJhas determined. "Des...
The US Food and Drug Administration (FDA) has granted accelerated approval to the novel gene therapyelivaldogene autotemcel(Skysona, bluebird bio) for the treatment of cerebral adrenoleukodystrophy (CALD). The therapy "is indicated to slow the progression of neurologic dysfunction in boys 4-17 yea...
BriaCell Therapeutics Corp. recently announced the US FDA has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the breast). The Fast Track designation will apply to patients with metastatic b...
FDA Commissioner Says Willing to Fast-Track COVID-19 Vaccine: FT More Reuters FILE PHOTO: Commissioner of U.S. Food and Drug Administration Dr. Stephen M. Hahn speaks during a news conference about the latest coronavirus disease (COVID-19) developments, in the Brady Press Br...
via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA)....
SanofiSNYannounced that the FDA has granted a Fast Track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people aged 50 years and above. NCT06695117, the first vaccine candidate, combines SNY’s influenza protein-based trivalent vaccine, Fluzone Hig...
FDA fast track designation has been granted to cell-based immunotherapy Bria-IMT for the treatment of patients with metastatic breast cancer. The FDA has granted fast track designation to cell-based immunotherapy Bria-IMT for the treatment of metastatic breast cancer, according to BriaCell ...
/PRNewswire/ -- Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food...