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Oncology FDA action reshapes first-line breast cancer ADC competition
Gilead’s Trodelvy won an FDA nod as a first-line triple-negative breast cancer treatment, with a slightly broader label designed to strengthen its position against other ADCs in the same line of...
Late-stage trial win boosts a path to market for ADHD therapy
Otsuka reported its phase 3b ADHD trial met its primary endpoint, strengthening the company’s case ahead of an expected U.S. regulatory decision. The positive readout arrives shortly before a...
Phase III monitoring partnership ties dd-cfDNA testing to kidney transplant immunotherapy
Natera and Eledon Pharmaceuticals partnered to embed Natera’s Prospera donor-derived cell-free DNA assay into a planned Phase III kidney transplant trial of Eledon’s tegoprubart, an...
Venture funding for preventive flu antibodies moves RQB01 toward clinic
RQ Bio raised $115 million in an oversubscribed Series A to advance RQB01, a single-dose antibody therapy designed for broad, season-long prevention of seasonal influenza. The London-based biotech...
New funding for decentralized molecular diagnostics targeting HPV
Intu Diagnostics raised €1.1 million in bridge funding as it develops a decentralized, electricity-free diagnostics platform using handheld cartridges for nucleic-acid amplification and visual...
ADC manufacturing and linker-payload licensing accelerates next-generation bispecific ADC efforts
Lonza signed a licensing agreement with InduPro to support development of antibody–drug conjugate programs using Lonza’s GlycoConnect and HydraSpace bioconjugation and proprietary linker-payload...
Biotech and clinical testing expansion for kidney transplant rejection risk
Verici Dx said its Tutivia lab-developed kidney transplant rejection risk test received approval from New York State’s Clinical Laboratory Evaluation Program, enabling nationwide availability....
China approval marks first CAR-T for solid tumors
China’s National Medical Products Administration approved Carsgen’s satricabtagene autoleucel (satri-cel, CT-041), positioning it as the first CAR-T therapy globally approved for solid tumors. The...
Sangamo enters bankruptcy after extended gene-editing platform run
Sangamo Therapeutics filed for Chapter 11 bankruptcy and simultaneously agreed to sell major portions of its platform assets, marking a sharp end to the company’s decades-long ZFN-era strategy....
FDA approval expands Trodelvy label
The FDA cleared expanded first-line use of Gilead’s antibody-drug conjugate Trodelvy (sacituzumab govitecan) for triple-negative breast cancer, adding label breadth that puts the drug in direct...
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...