Get the Daily Brief
Latest Biotech News
U.S. HHS rolls out Operation Trailblazer to speed early drug development and IND starts
The U.S. Department of Health and Human Services has published a blueprint under Operation TrialBlazer aimed at narrowing gaps in early-stage clinical development speed, particularly for...
FDA-approved genome sequencing expands outpatient exome/genome testing coverage
Carelon has updated its outpatient clinical appropriateness guidelines to include whole-exome sequencing (WES) and whole-genome sequencing (WGS) for defined outpatient scenarios. The change,...
Gilead gains regulatory expansion – Tryngolza label for triglycerides and pancreatitis
Ionis has won an FDA label expansion for Tryngolza (treatment for severe hypertriglyceridemia), expanding the drug’s commercial address beyond prior use cases. The approval also ties the therapy...
China approves first CAR T for solid tumors – satricabtagene autoleucel
China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel), marking the first global approval of a CAR T therapy for solid tumors....
Gene editing startup Serapha launches with $230M and Chinese base-editing license
Serapha Bio launched with $230 million in total funding commitments, combining $138 million in Series A funding led by RA Capital and RTW Investments with an additional $92 million tied to a...
Sangamo files for Chapter 11 – Lilly and Astellas line up stalking-horse bids
Sangamo Therapeutics has filed for Chapter 11 bankruptcy protection and simultaneously arranged asset-sale agreements with Eli Lilly and Astellas, set up as stalking-horse bids for specific...
Ollin raises $330M for Phase 3 trials of Vabysmo challenger in eye disease
Ollin Biosciences raised $330 million in a Series B to advance a Phase 3 program for its Vabysmo challenger, targeting diabetic macular edema and wet age-related macular degeneration. The funding...
RQ Bio raises $115M to advance long-acting flu prevention antibody into clinic
RQ Bio raised $115 million in a Series A to advance RQB01, a preclinical antibody program designed for broad, long-lasting seasonal influenza prevention. The company is targeting a “differentiated...
BIO 2026 policy and security messaging highlights U.S. biotech leadership needs
At BIO 2026, biotech leadership tied U.S. biotech competitiveness directly to patient access and national security, arguing that outdated regulation and funding gaps could erode U.S. leadership....
U.S. regulatory approvals expand label for targeted therapies
The FDA has approved palbociclib with trastuzumab, with or without pertuzumab, plus endocrine therapy for adults with HR-positive, HER2-positive advanced breast cancer following results from the...
Regulatory approvals for liquid biopsy MRD tests in Japan
Japan’s PMDA has approved Natera’s Signatera colorectal cancer molecular residual disease (MRD) assay for neoadjuvant use, supported by data from the GALAXY arm of the CIRCULATE-Japan program....
FDA trust in clinical trial integrity challenged and retracted
Nature Medicine has retracted a randomized phase 3 trial publication, “Time-of-day immunotherapy in non-small cell lung cancer,” after identifying major problems with the trial and losing...
FDA panel and regulatory speed strategy for early-stage drug development
The U.S. Department of Health and Human Services is advancing a blueprint to speed early Rx development as part of Operation Trailblazer, aiming to reduce burdens for companies preparing...
China’s CAR-T milestone in solid tumors
China’s NMPA approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), positioned as the first global CAR-T approval for solid tumors. The Claudin18.2-targeted, autologous...
Biotech dealmaking and restructuring signals around major platforms
Passage Bio is moving to exit its strategic review after tough FDA feedback, agreeing to a reverse merger with Remix Therapeutics. The all-stock transaction transfers the Nasdaq listing path to...
Large drugmaker M&A expansion tied to GLP-1 cash generation
Eli Lilly is using cash flow from tirzepatide products to drive a broad M&A campaign, with $25.1 billion in announced acquisitions across 10 deals during 2026. The largest transaction flagged is a...
Big pharma deals for undruggable oncology targets
Novartis agreed to fund Antares Therapeutics with $105 million upfront and total consideration up to $1.9 billion to discover small-molecule programs against oncology targets deemed “undruggable.”...
Gene-editing and regional manufacturing partnerships for rare disease therapy development
Abu Dhabi’s Department of Health and M42 signed an MOU with Mammoth Biosciences to support preclinical CRISPR-based development for severe hypertriglyceridemia and familial chylomicronemia...
Biotech financing and manufacturing scaling: new FDA label access for triglyceride therapy
Ionis won an FDA label expansion for its antisense therapy Tryngolza (landing an additional indication aimed at severe hypertriglyceridemia and related pancreatitis risk). The company said the...
FDA expands Ionis lipid drug label for severe hypertriglyceridemia
Ionis Pharmaceuticals said the FDA granted a label expansion for its antisense therapy Tryngolza to reduce triglycerides and treat patients with severe hypertriglyceridemia and associated...