A head-to-head readout would strengthen Novo's position in an obesity market where Eli Lilly's Zepbound has gained ground.

The global license gives Novo an extended-release delivery platform as it seeks durable obesity and diabetes franchises.

The expansion of international reference pricing to Medicaid broadens the policy's reach across government-backed drug purchasing.

An FDA clearance in an ultra-rare indication adds a new commercial asset for Mirum's pediatric rare disease portfolio.

An approval in IgA nephropathy gives Vera its first commercial product in a competitive rare kidney disease field.

The Korean company's first US oncology approval is being watched as a test of investor sentiment toward its pipeline.

Analysts are split on deramiocel's approvability after FDA briefing documents raised concerns ahead of a decision.

H.C. Wainwright called the filing approach risky after the company hit a regulatory obstacle for its oncology antibody.

Legal inquiries followed an FDA letter, pressuring shares of the hematology-focused developer.

The Korean biotech is balancing regulatory and investigative pressure against advancing clinical programs.

Late-stage success would mark a milestone for in vivo CRISPR-based therapies.

The voluntary BLA withdrawal delays a DXd antibody-drug conjugate in a hard-to-treat lung cancer setting.

The resubmission follows a broader push to expand Anktiva's label, with the chairman citing diplomatic help for the cancer drug.

The contract manufacturer's results point to recovering API demand in the Indian pharma supply chain.

The Indian generics maker posted record quarterly results and outlined its outlook on a follow-up call.

The trial failure is a major setback for the small-cap cell therapy developer.

Retail interest built around an upcoming Phase 3 readout for the company's cancer vaccine candidate.

The filing acceptance moves a non-dopamine Tourette's treatment toward a potential US launch.