Latest Biotech News

FDA’s acting gene therapy regulator Vijay Kumar is stepping down from his role, according to an email obtained by STAT. The exit follows a broader leadership shakeup inside the agency’s Center for...

The EMA reversed its earlier stance on Acadia Pharmaceuticals’ trofinetide (Daybu), moving from a February rebuff to a CHMP recommendation to approve the therapy for neurobehavioral symptoms of...

The FDA cleared Viridian Therapeutics’ IGF-1R antagonist Lumvoa (veligrotug-vvze) for thyroid eye disease, giving the company its first commercial product and setting up direct competition with...

Zymeworks agreed to acquire Theravance Biopharma in a $929 million deal designed to strengthen the company’s royalty stream and late-stage exposure. The transaction gives Zymeworks partial rights...

Ipsen is buying Kartos Therapeutics for $450 million upfront to acquire navtemadlin (an MDM2-targeting p53 reactivator) as Kartos’ Phase 3 program advances in myelofibrosis. The oral small...

Roche began shipping Axelios 1, its next-generation sequencing platform positioned as a challenge to Illumina’s dominance. The company is rolling out the system commercially with an initial focus...

Samsung Bioepis reported positive topline results from parallel-run Phase 1 and Phase 3 studies for SB-27, a proposed biosimilar to Merck’s Keytruda (pembrolizumab). The company said preliminary...

Aveta Biomics selected Natera’s ctDNA test Signatera to measure minimal residual disease in its Phase 3 head and neck squamous cell carcinoma trial. The biomarker strategy uses Signatera across...

Shilpa Biologicals commissioned an integrated ADC drug substance GMP manufacturing facility in India, with full operations and GMP qualification protocols underway. The build is designed to meet...

Researchers escalated concerns about image manipulation in antibody validation data after OXB scientist Sholto David flagged suspicious western blot results on Thermo Fisher Scientific’s vendor...

The New England Journal of Medicine has retracted what Amgen described as pivotal data for its autoimmune therapy Tavneos, following author requests for removal. The step adds another regulatory...

BridgeBio Pharma-backed infigratinib scored a statistically significant win in a Phase 3 NEJM trial for children with achondroplasia, improving multiple growth endpoints versus placebo over 52...

Ipsen moved to deepen its myelofibrosis pipeline by agreeing to acquire Kartos Therapeutics for $450 million upfront, taking control of navtemadlin in Phase 3 testing. The oral small molecule aims...

Genedrive and Thermo Fisher struck a partnership to develop a CYP2C19 multiplex PCR pharmacogenetic test for use on Thermo Fisher’s QuantStudio 5 Dx platform. The test is designed for centralized,...

Viridian Therapeutics won U.S. FDA clearance for Lumvoa (veligrotug-vvze) for thyroid eye disease, with labeling covering both chronic and active phases. The approval positions the IGF-1R...

Samsung Bioepis reported positive top-line results for SB-27, its proposed biosimilar to Merck’s Keytruda (pembrolizumab), including Phase 1 and Phase 3 endpoints. The company said parallel-run...

Roche began shipping its Axelios 1 next-generation sequencing platform commercially, targeting accuracy, speed, flexibility, scalability, and cost efficiency. The company said the rollout starts...

Aveta Biomics tapped Natera’s Signatera ctDNA assay to measure minimal residual disease in a Phase 3 trial of APG-157 for locally advanced head and neck squamous cell carcinoma. The study plans to...

Antares entered a discovery and commercialization collaboration with Novartis to pursue small-molecule medicines against oncology targets previously viewed as difficult to drug. Antares will...

China’s NMPA issued updated Good Clinical Practice regulations that come into force in September, adding new emphasis on data governance and compliance with international ethical principles. The...