Latest Biotech News

BeOne Medicines reported that Brukinsa (zanubrutinib) lowered the risk of disease progression or death by 43% versus chemoimmunotherapy when used as a first-line treatment in mantle cell lymphoma,...

The FDA’s top gene therapy regulator is stepping down, according to an email reported by STAT. Vijay Kumar, acting director of the Office of Therapeutic Products (cell and gene therapy review) at...

Researchers and investigators escalated concerns over antibody validation images after they found apparent manipulation in vendor-supplied western blot data. A dispute over what Thermo Fisher did...

More than 200 biopharma investors and firms urged EU member states to strengthen Europe’s life sciences sector in an open letter. The signatories pushed for policy changes aimed at improving the...

Natera’s Signatera ctDNA test will be used as a minimal residual disease endpoint in Aveta Biomics’ Phase 3 trial of APG-157 in locally advanced head and neck squamous cell carcinoma. The study...

Roche began commercial shipping of Axelios 1, a new next-generation sequencing platform designed to compete with Illumina in accuracy, speed, flexibility, scalability, and cost. The launch signals...

The FDA cleared Viridian Therapeutics’ Lumvoa (veligrotug-vvze) for thyroid eye disease, giving the IGF-1R antagonist a route into both active and chronic phases. The approval sets up competition...

Zymeworks agreed to acquire Theravance Biopharma for about $929 million, paying $17 per share, to add commercial and late-stage COPD exposure through Theravance’s Yupelri profit stream. The...

A Phase 3 trial in NEJM.org reported that once-daily oral infigratinib significantly improved height outcomes in children with achondroplasia versus placebo over 52 weeks. The primary...

ACRO urged the FDA to include contract research organizations directly in the agency’s AI trial pilot for early-phase studies. The group said CROs should participate as primary stakeholders rather...

The FDA’s acting gene-therapy leadership is changing as Vijay Kumar steps down from his role overseeing the Office of Therapeutic Products within CBER, according to an email obtained by STAT....

Viridian Therapeutics won FDA approval for Lumvoa (veligrotug-vvze), an IGF-1R antagonist for thyroid eye disease, clearing the way for competition with Amgen’s Tepezza. The FDA clearance covers...

BridgeBio Pharma’s infigratinib produced significantly greater improvements than placebo in a Phase 3 trial in children with achondroplasia, according to data published in the New England Journal...

Ipsen agreed to acquire Kartos Therapeutics in a $450 million upfront deal, bringing navtemadlin—an MDM2-targeting, p53-restoring approach—into Ipsen’s pipeline. Kartos’ program has reached Phase...

Zymeworks will acquire Theravance Biopharma for about $929 million upfront, adding commercial COPD exposure via Yupelri (revefenacin) and expanding late-stage and royalty-linked optionality. The...

Abivax disclosed additional safety data for obefazimod, its experimental ulcerative colitis maintenance therapy, and the update appears to have eased recent investor concerns. Shares rose sharply...

Tecan integrated agentic AI capabilities into its Introspect lab analytics platform, using NVIDIA’s BioNeMo Agent Toolkit to move from monitoring to proactive lab operations. Tecan said the...

Roche began shipping Axelios 1 commercially, positioning its next-generation sequencing platform as a direct challenge to Illumina’s installed base. The company said initial distribution will...

Genedrive partnered with Thermo Fisher Scientific to develop a CYP2C19 pharmacogenetic in vitro diagnostic kit designed for Thermo Fisher’s QuantStudio 5 Dx platform. The test targets clopidogrel...

China’s National Medical Products Administration published revised Good Clinical Practice regulations that take effect in September, introducing updated rules on clinical data governance and...