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

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

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 ...

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

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

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

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 ...

The licensing pact adds a second so-called "triple agonist" to the Danish drugmaker's portfolio as competition with Lilly and ...

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

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