Since the first-generation CAR-Ts reached the market several years ago, clinicians have become more adept at handling ...

REMS is a useful safety system, 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, M.D., M.P.H.

REMS is a useful safety system, 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 ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Changing how biopharmas package their products, how regulators review new drugs and how mutated genes are fixed could make ...

The U.S. Food and Drug Administration (FDA) recently announced it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved BCMA- and CD19-directed ...

During his Senate confirmation hearings, Health Secretary Robert F. Kennedy Jr. suggested he wouldn’t undermine vaccines. “I ...

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain ...

During his Senate confirmation hearings, Health Secretary Robert F. Kennedy Jr. suggested he wouldn’t undermine vaccines. “I ...

Some of us believe in civil debate and discussion, even though Drs. Vinay Prasad, Marty Makary, and Jay Bhattacharya do not.

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said the agency’s new risk-based COVID-19 vaccine framework contradicts the ...