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A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...
FDA vaccines chief Vinay Prasad limited broader use of COVID vaccines, citing reduced risk and data concerns. Read more here.
FDA officials have determined that information regarding the risks for six CAR T-cell therapies can be communicated through product labeling, which includes a boxed warning for the risks of cytokine ...
IOVA's ASCO update reiterates the value of Amtagvi in melanoma, but upcoming data in lung cancer and endometrial cancer in H2'25 might have a bigger ...
Cell and gene therapy leaders say the agency’s decision to remove the Risk Evaluation and Mitigation Strategies that had been ...
Note that some links may require registration or subscription. A 35-year-old gastroenterologist pleaded guilty to sexually ...
The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...
The FDA has removed Risk Evaluation and Mitigation Strategies (REMS) for approved chimeric antigen receptor (CAR) T-cell therapies for hematologic malignancies, aiming to ease provider burden and ...
Previously, due to the risk of cytokine release syndrome and neurological toxicities, many CAR T-cell therapies included a REMS requirement.
The FDA is eliminating of Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed CAR ...
but reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,” said FDA Vinay Prasad, Chief Medical and Scientific Officer and ...