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Breakthrough immunotherapy targeting and delivery
Preclinical data from Weill Cornell Medicine and Roswell Park Comprehensive Cancer Center show that intravesical CAR T cells can control bladder tumors in mice. In a Journal of Experimental...
Funding and launch of new inflammatory disease biologics platform
Bionyra Pharma emerged from stealth after raising $165 million in an oversubscribed Series A to develop next-generation biologics for severe immunological and inflammatory diseases. The...
Cell and gene therapy business development and tech platforms
Moderna disclosed its first in vivo CAR-T program, aiming to move an autoimmune disease candidate into clinical development next year. The company framed the approach as an off-the-shelf...
High-stakes clinical and regulatory trial milestones in cardiometabolic disease
Ionis Pharmaceuticals secured a wider FDA approval for Tryngolza (olezarsen), expanding the therapy’s use into adults with severe hypertriglyceridemia. The approval follows phase III data...
Drug approvals that reshape oncology ADC competition
Gilead’s Trodelvy won an expanded FDA approval for first-line triple-negative breast cancer, enabling use regardless of PD-L1 status. The expanded label supports both monotherapy and combination...
AI in drug discovery—model validity, not model hype
A commentary piece directly challenges the idea that AI can compensate for preclinical models that don’t reflect patient tumor biology. The analysis argues that higher data volumes and better...
Evidence integrity in high-impact oncology publications
Nature Medicine retracted a high-profile Chinese lung cancer study after questions about protocol adherence and randomization patterns. The paper, known as Lungtime-C01, had claimed that giving...
Major merger to expand life-science tools and workflows
Merck KGaA agreed to acquire Bio-Techne in a deal valued at about $11.3 billion, its biggest acquisition in more than a decade. The transaction is structured around a $73 per share cash offer and...
CAR-T target discovery using human-in-the-loop AI
Researchers at the University of Pennsylvania presented an AI-enabled, human-in-the-loop framework to identify next-generation CAR T targets with multi-cancer potential. Published in Cell, the...
FDA approvals expanding immunotherapy use
The FDA expanded Gilead’s Trodelvy label into front-line triple-negative breast cancer (TNBC), giving TROP2 ADCs a new footing in first-line treatment. The update allows Trodelvy to be used in...
Drugmakers pursue regulatory paths after setbacks
Replimune’s oncolytic immunotherapy RP1 cleared an FDA acceptance hurdle for a third regulatory attempt in advanced melanoma, with a decision expected on or before Aug. 2. The FDA has also...
AI-enabled target discovery for next-generation CAR-T
Researchers at the University of Pennsylvania unveiled an AI-assisted pipeline to nominate and validate CAR-T targets for solid tumors, spotlighting GPNMB as a multi-cancer candidate. The work,...
Regenerative medicine and diagnostic modernization funding
ARPA-H committed $90.7 million over four years through its Making Obstetrics Care Smart (MOCS) program to speed point-of-care diagnostics and monitoring approaches designed to improve childbirth...
Big Tech M&A for life science tools and diagnostics
Merck KGaA agreed to acquire Bio-Techne in an $11.3 billion deal, positioning the company to expand its life sciences tools, analytics, and workflows across discovery and advanced therapeutics....
Diagnostics product development and FDA filing
BioMérieux submitted a rapid multiplex syndromic vaginitis panel to the FDA for dual 510(k) clearance and CLIA waiver, aiming to bring point-of-care molecular results to women’s health settings....
Biosecurity and U.S.-China biotech deal scrutiny
At BIO 2026, U.S. biotech executives highlighted mounting tension around U.S.-China licensing deals, where lawmakers are weighing new restrictions amid national security and competition concerns....
Funding rounds for prophylactic and platform drug programs
RQ Bio raised an oversubscribed $115 million Series A to advance its long-acting antibody prophylaxis program for seasonal influenza. The financing is intended to move RQB-01 toward IND-enabling...
Molecular diagnostic and oncology assay commercialization
Myriad Genetics expanded access to its Precise MRD ctDNA assay across breast, colorectal, and renal cancers, extending use from treatment through surveillance. The ultrasensitive whole-genome...
Infectious disease therapeutics using fully human antibody combinations
An international team led by Icahn School of Medicine at Mount Sinai reported a fully human monoclonal antibody cocktail that provides complete protection against Nipah and Hendra virus infection...
US public R&D funding for obstetrics diagnostics and fetal monitoring
ARPA-H has committed $90.7 million over four years under its Making Obstetrics Care Smart (MOCS) program to accelerate diagnostic tests and fetal monitoring tools aimed at improving childbirth...