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

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 ...

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

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

The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.

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 ...

The Washington, D.C.–Baltimore area ranks in the top six for life sciences R&D and manufacturing talent, according to a CBRE report. The Maryland Department of Commerce’s director of life sciences ...

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