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 ...

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

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

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 ...

Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a ...

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

More than one quarter of the medcines cleared by the FDA’s main review office since 2015 have been cancer drugs, a tally that ...

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

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

Many HHS department heads and staff were unaware of plans to fire some 10,000 employees until they were publicly disclosed ...