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Capital flows: Oblenio Bio lands $62M Series B for autoimmune T-cell engager
Oblenio Bio raised $62 million in an oversubscribed Series B led by Pfizer Ventures to advance a trispecific T-cell engager (TCE) for autoimmune disease into a first-in-human study. The financing...
Eli Lilly’s AI-enabled hair-loss bet: Absci investment
Eli Lilly invested in Absci, putting $40 million into the AI startup in a $50 million funding round that centers on a medication designed to stimulate hair growth, with potential additional...
Genomics and MRD: Natera wins Japan PMDA clearance for Signatera in neoadjuvant CRC
Natera said Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved its Signatera liquid biopsy molecular residual disease (MRD) assay for colorectal cancer in the neoadjuvant setting....
Gene editing turnaround: Serapha launches with $230M and Boundless reverse merger
Serapha Bio launched via an all-stock reverse merger with Boundless Bio and raised $230 million in combined funding commitments led by RA Capital and RTW Investments to develop an in vivo base...
Sangamo exits gene editing: Chapter 11 and asset sale to Lilly and Astellas
Sangamo Therapeutics filed for Chapter 11 bankruptcy and agreed to sell key assets through stalking horse bids, with Eli Lilly set to acquire Sangamo’s capsid delivery, zinc finger nuclease and...
CAR-T regulatory milestone in China for solid tumors
China’s National Medical Products Administration approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid...
FDA and policy reform: HHS/Operation Trailblazer to speed early drug development
The U.S. Department of Health and Human Services released a blueprint to speed early clinical development via Operation Trailblazer, aiming to reduce friction in Investigational New Drug (IND)...
Precision oncology diagnostics: Quest approval for Haystack MRD test nationwide rollout
Quest Diagnostics received New York approval for its Haystack MRD test for detecting residual or recurring disease across a range of solid tumors, with the company stating the authorization...
Influenza prophylaxis investment: RQ Bio raises $115M Series A for long-acting antiviral antibody
RQ Bio raised $115 million in a Series A led by Frazier Life Sciences to advance RQB01, a preclinical long-acting antibody program intended to provide season-long prevention of seasonal influenza....
FDA expands Trodelvy to first-line triple-negative breast cancer
FDA has expanded Gilead’s Trodelvy (sacituzumab govitecan-hziy) to a first-line treatment setting for adults with HR-positive, HER2-negative advanced breast cancer?—no, specifically for...
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...