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

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

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

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...

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

To meet the requirements for FDA Breakthrough Device Designation, CDx Diagnostics submitted technical and clinical evidence ...

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 ...

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

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

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for ...