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 ...

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

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 ...

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

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