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 ...

The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.

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

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

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

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 ...

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

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

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

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