Ultragenyx Pharmaceuticals chalked up another win for its rare bone disease drug, burosumab, keeping it on track for a U.S. regulatory filing.

Australia’s Prescient Therapeutics is getting its lead cancer program back on track, with two trials subject to FDA clinical hold cleared to resume.

Shares in DBV rose on the back of the data, going a little way to erasing the big drop it suffered after missing its primary efficacy endpoint.

The action marks the end for an oral adenosine A2a receptor antagonist Acorda paid $363 million in cash for last year.

The framework builds on the 21st Century Cures Act by setting criteria for the RMAT designation and outlining the benefits of the regulatory status.

The gene silencing pioneer expects to complete the submission by the end of the year, setting it up to win approval in the U.S. in 2018.

Shares in Acorda Therapeutics are sliding following the news that the company’s Parkinson’s drug has been linked to a potentially fatal side effect.

FDA Commissioner Scott Gottlieb has hit back at plans that could see the Pentagon take control over the approval of some experimental drugs and devices for…