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

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

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 ...

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

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

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

Tidmarsh, an adjunct professor at Stanford’s medical school, brings decades of industry experience to the table. Serving as ...

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

Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy ...