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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...
FDA backs Gilead’s Trodelvy for first-line triple-negative breast cancer
The FDA approved Gilead’s Trodelvy for first-line treatment of triple-negative breast cancer (TNBC), adding a second authorization for Trodelvy shortly after the agency cleared a rival breast...
China clears first CAR T for solid tumors
China’s National Medical Products Administration approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global authorization for a CAR T therapy in solid...
Antares and Novartis strike $1.9B pact for undruggable cancer targets
Novartis will collaborate with Antares Therapeutics on small-molecule discovery against oncology targets considered “undruggable,” in a deal valued up to $1.9 billion with a $105 million upfront...
AbbVie to acquire Apogee Therapeutics in $10.9B immunology deal
AbbVie agreed to acquire Apogee Therapeutics for about $10.9 billion, adding zumilokibart (APG777), a long-acting, subcutaneous IL-13–targeting monoclonal antibody, to AbbVie’s immunology...
Sangamo files for Chapter 11 as Lilly and Astellas line up for key assets
Sangamo Therapeutics filed for Chapter 11 bankruptcy and agreed to asset sale terms with Eli Lilly and Astellas as “stalking horse” bidders, seeking to monetize major parts of its platform. The...
Eli Lilly invests $50M led by Absci AI startup for hair growth and beyond
Absci announced a $50 million funding round led by Eli Lilly, with Lilly investing $40 million for equity in the Nasdaq-listed startup. Absci’s program focus includes developing a medication...
RQ Bio raises $115M Series A for long-acting, broad flu prevention antibody
RQ Bio secured a $115 million Series A to advance RQB01, a preclinical, long-acting antibody program aimed at preventing seasonal influenza with broad protection. The company said the candidate...
UCI Health begins first-in-human embryonic stem-cell neural stem cell trial for Huntington’s
UCI Health launched a Phase Ib/IIa clinical trial evaluating hNSC-01, an embryonic stem cell-derived neural stem cell therapy for Huntington’s disease. The trial uses neural stem cells delivered...
Nature retracts LungTIME-C01 timing-of-immunotherapy phase 3 findings
Nature Medicine retracted a randomized phase 3 study claiming time-of-day immunochemotherapy improves outcomes in non-small cell lung cancer, citing multiple problems and lack of editorial...
ADC Therapeutics reorganizes amid Zynlonta safety concerns
ADC Therapeutics is cutting about 17% of staff as it focuses resources behind Zynlonta after safety concerns surfaced in a confirmatory study, the company said in a June 24 release. The Swiss ADC...