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 ...

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

The drug discovery company, which has partnerships with Eli Lilly and Novartis, is developing AI models to design drugs and ...

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

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

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 ...

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

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

A Texas judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to ...