FDA’s new accelerated pathway may open pharma up to risks, as well as benefits

Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.

Novo strikes RNA drug deal with startup Replicate

The agreement provides research funding for Replicate and up to $550M in payments to develop medicines for diseases including obesity and diabetes.

Scale AAV production with peace of mind

RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial

Cemdisiran helped control symptoms of generalized myasthenia gravis, but combination treatment with a Regeneron antibody didn't appear as effective.

Drugs from China are reshaping biotech. Track the licensing deals here.

Biopharmaceutical firms in the U.S. and Europe are turning to China’s biotech sector for new medicines, with licensing hitting a record pace in 2025. Follow this year’s dealmaking with this database.

FDA cancels adcomm on Biohaven drug; Catalent lays off staff

Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff at a gene therapy facility.

One brother approved, one denied for same gene therapy

Fresenius debuts European consortium to pursue bedside CAR-T production