The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...

The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

The company didn’t share specific data for the molecule, gefurulimab, but said it hit all endpoints in the Phase III PREVAIL ...

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched ...

Roche obtained CT-173, a PYY mimetic, in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. The company ...

The latest round of terminations, which will take effect Sept. 15, comes after Genentech fired more than 500 employees in the ...

Companies sometimes miss the mark when it comes to telling employees they’re out of a job. From accidental goodbyes to ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

The decision follows last month’s vote of the CDC’s revamped vaccine advisory committee. Thimerosal, mostly removed from ...

Dispatch seeks to address two main challenges of immunotherapies in solid tumors: the lack of a target and the ...

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...