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 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 ...

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.

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 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 ...

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

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