The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...

More than three-quarters of private biotech investment tracked by BioPharma Dive between January and March was distributed ...

In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed ...

The FDA will lose about 3,500 employees under the plans, although HHS said drug, medical device and food reviewers will not ...

Cellular Therapies and IDRx, crossed the $1 billion mark, a notable decrease from the six seen during the same period last year.

Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as ...

Artis BioSolutions joins a host of startups trying to improve development and manufacturing capacity for cutting-edge gene ...

Shares in Moderna, Vaxcyte, Novavax and BioNTech all fell Monday after Peter Marks, head of the FDA office that reviews ...

Teams working on device communications and policy were cut from the agency on Tuesday, according to multiple FDA workers.

The sweeping workforce reduction that began Tuesday was made worse by mistakes and poor communication, including directions ...

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of ...