Latest Biotech News

Ultragenyx has agreed to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $210 million, the company said, tying the voucher to FDA approval of its one-time gene therapy GENGLYCOS...

Roche has entered a large obesity licensing deal with Rona Therapeutics for an ALK7 inhibition asset, according to the report. The agreement includes up to $100 million in upfront and near-term...

Asahi Kasei Therapeutics received FDA approval for Hovilpri, a new oral treatment for herpes simplex virus lesions, after acquiring the program in an approximately $1 billion deal earlier this...

Early gluten-challenge clinical results are sharpening attention on dosing strategies for CD122-targeting therapies in celiac disease. The report highlights Phase I readouts for First Tracks...

Undecimal Bio launched with $18 million, after spinning out one half of Eleven Therapeutics this summer. The new company aims to advance siRNA programs beyond liver disease, positioning its lead...

Syndax is ending development of Niktimvo for idiopathic pulmonary fibrosis after a Phase 2 failure, the report says. The placebo-controlled study did not deliver the hoped-for clinical benefit,...

Viatris has agreed to acquire Pacira BioSciences in a deal valued at about $1.65 billion, the report says. The transaction would give Viatris established non-opioid analgesic products including...

Brent Saunders is stepping down as CEO of Bausch + Lomb, according to the report, ending his roughly three-year tenure. The exit comes without another multibillion-dollar acquisition, setting up a...

MIT researchers engineered ligand-directed lipid nanoparticles designed to reprogram natural killer cells in vivo into CAR-bearing cancer killers without viral vectors. In preclinical animal...

Three-year follow-up from KEYNOTE-966 continues to support pembrolizumab added to gemcitabine and cisplatin in advanced biliary tract cancer, with durable overall survival benefit and no new...

Roche announced it will sign a major obesity-focused licensing deal with Rona Therapeutics, centered on an ALK7 inhibition asset. Under the terms disclosed, Roche is expected to pay up to $100...

Caribou Biosciences initiated a strategic review after its stock extended losses, and the company said it would halt trials of its two clinical-phase allogeneic CAR-T programs while executing...

Asahi Kasei Therapeutics received FDA approval for Hovilpri, a new oral treatment for lesions caused by herpes simplex virus infection. The approval follows Asahi Kasei’s acquisition of AiCuris...

Viatris agreed to acquire Pacira BioSciences in a deal valued at about $1.65 billion, acquiring the company’s established pain portfolio including Exparel and Zilretta. The transaction is priced...

Concerns are escalating around Neurocrine Biosciences’ rare-disease drug Vykat XR for Prader-Willi syndrome after patient advocates and some external experts raised safety alarms in the wake of an...

First Tracks Biotherapeutics reported positive early clinical data for its CD122 antibody ANB033 in a placebo-controlled Phase I study in celiac disease. The company said the program met primary...

Biliary tract cancer continues to show durable benefit with pembrolizumab plus chemotherapy. Three-year follow-up of the phase 3 KEYNOTE-966 trial confirmed an ongoing overall survival advantage...

Johns Hopkins Medicine’s team published clinical validation supporting what is described as the first FDA-cleared rapid urine test to aid diagnosis of invasive aspergillosis. The clearance is...

A Chinese clinical study reported donor-derived anti-CD19 CAR-T results in patients whose B-cell acute lymphoblastic leukemia relapsed after stem-cell transplant. The trial reported complete...

Recent US policy coverage highlights how the 2026 CMS physician fee schedule final rule expands documentation and reporting burdens for drug manufacturers tied to ASP and service fee processes,...