The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...

A Food and Drug Administration official who stepped down less than two weeks ago is getting his job back as the agency’s top ...

Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the U.S. Food and Drug ...

Vinay Prasad, M.D., has rejoined the FDA, the latest turn in a monthslong stretch of leadership turnover at the agency. | “At ...

WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene ...

The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

Dr. Vinay Prasad had been serving as the FDA's director of the Center for Biologics Evaluation and Research since May, and ...

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA ...

Less than weeks after stepping down, Prasad will return to lead CBER “at the FDA’s request,” according to an HHS spokesperson ...

Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated ...

The gene therapy chief wanted to block fast-track drug approvals.