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 ...

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

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

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

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

Airna will use the Series B round to launch a Phase 1/2 trial of its lead program for alpha-1 antitrypsin deficiency, a ...

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

The new bid surpasses an offer SK Capital and Carlyle Group made last month for the gene therapy developer, which Bluebird’s ...

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

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients ...

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