Vinay Prasad—the controversial head of vaccine regulation at the US Food and Drug Administration (FDA)—has been named FDA chief medical and scientific officer.1 Traditionally separate roles, his new ...

The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

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 ...

Capricor's DMD therapy Deramiocel is under FDA Priority Review with no major issues flagged; PDUFA date set for August 31, 2025.

Restricted availability under an FDA-mandated drug safety program has limited the reach of CAR-T cell therapies for certain blood cancers—until now. | The FDA has removed the REMS requirements for ...

Controversial doctor Vinay Prasad, a public health researcher at UCSF known as a critic of US health policy, has been named as director of the FDA's Center for Biologics Evaluation and Research ...

Capricor stock drops as FDA cancels advisory meeting on Duchenne therapy; leadership changes and regulatory tensions fuel uncertainty.

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety ...

Nicole Verdun, MD, super office director of the FDA’s Office of Therapeutic Products (OTP) and her deputy Rachael Anatol, PhD ...

When Americans imagine the future, it always has a lot to do with flying cars, robot housekeepers, and just about anything ...

In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...

In the wake of Marks' exit, FDA Commissioner Marty Makary, M.D., named Vinay Prasad, M.D., to head up the CBER. In addition to that title, Prasad recently added the title of "chief medical and science ...