Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...
The FDA is expected to decide on the BLA for tabelecleucel, an allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy. The application seeks approval for the treatment of adult and ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...
Hosted on MSN
Dr. Gottlieb: FDA is systemically trying to dismantle components of the vaccine approval process
Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss concerns over the FDA's sweeping changes to how the U.S. handles vaccinations, impact on the public trust in vaccines, ...
The FDA is accelerating approval for sibeprenlimab, a monoclonal antibody that inhibits APRIL in IgAN pathogenesis. The US Food and Drug Administration (FDA) has granted accelerated approval status to ...
The nation’s top drug regulator, Richard Pazdur, has decided to retire three weeks after taking the job. Pazdur privately mused last month about retiring from the Food and Drug Administration or ...
A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific officer Vinay ...
A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that Covid-19 vaccination resulted in the deaths of 10 children. In an ...
With a fresh FDA endorsement for its drug plozasiran, California-based Arrowhead Pharmaceuticals has successfully broken through to the commercial realm. Complicating the matter, however, is the fact ...
Dr. Richard Pazdur, who has been the F.D.A.’s top cancer drug regulator, represents a stabilizing choice for an agency reeling under staff cuts and low morale. By Christina Jewett and Rebecca Robbins ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback