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FDA grants fast-track to EpCAM-directed Probody ADC in metastatic colorectal cancer
The FDA granted Fast Track designation to CytomX Therapeutics’ varsetatug masetecan (Varseta-M; CX-2051), an EpCAM-directed, masked, conditionally activated antibody–drug conjugate (ADC), for...
Late-stage epilepsy deal expands U.S. commercialization options
SK Biopharmaceuticals expanded its U.S. prospects by licensing opakalim, a Kv7-targeting small molecule from Biohaven for epilepsy. Biohaven outlicenced global rights to SK Biopharmaceuticals to...
AstraZeneca’s oral relaxin agonist posts mixed signal in mid-stage heart failure trial
AstraZeneca’s oral relaxin agonist showed improvement in cardiac function for some patients in a mid-stage trial, though the overall results were described as a partial success. The study’s mixed...
Arrowhead reports Redemplo safety edge over Ionis in triglyceride race
Arrowhead Pharmaceuticals said its RNA interference drug Redemplo looked safer as well as effective in two late-stage triglyceride trials, positioning the program as a potential competitive...
iPSC-derived CD4 helper T-cell generation supports next-gen off-the-shelf CAR T
Boston University researchers reported a scalable method to generate CD4+ helper T cells from induced pluripotent stem cells (iPSCs) using a Notch signaling strategy. In a Stem Cell Reports study,...
First clinical CAR T remission signal in refractory rheumatoid arthritis
A small Phase 1 trial at Charité—Universitätsmedizin Berlin reported that CD19 CAR T-cell therapy (mivocabtagene autoleucel; miv-cel) drove substantial reductions in disease activity in six...
Cancer imaging: FAPI-04 PET/CT outperforms FDG for post-surgical breast cancer recurrence detection
FAPI-04 PET/CT outperformed FDG in detecting recurrent breast cancer after surgery in a head-to-head comparison, according to results published in the European Journal of Nuclear Medicine. The...
Biotech IP: 10x says jury found willful infringement by Parse Biosciences on Evercode WTA patents
A U.S. jury found that Parse Biosciences, a subsidiary of Qiagen, willfully infringed three patents owned by Scale Biosciences (acquired by 10x Genomics in 2025), upholding the validity of those...
Public-health surveillance meets mRNA-era accountability: hepatitis A vaccination meta-analysis
A systematic review and meta-analysis in eClinicalMedicine concluded that hepatitis A vaccines prevent about 96% of infections when given before exposure and about 97% when administered after...
FDA approvals in cardiometabolic disease
The U.S. FDA approved Eli Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes, expanding the drug’s label beyond glycemic control and weight loss. The...
FDA clears oral relaxin agonist in heart failure
AstraZeneca’s oral relaxin agonist posted a mid-stage readout suggesting potential benefit in a heart-failure population, but not uniformly across all groups. Presented at ESC and reported from...
FDA expands immune-oncology options via oncology designations
The FDA granted fast track designation to CytomX Therapeutics’ EpCAM-directed, masked, conditionally activated antibody-drug conjugate varsetatug masetecan (Varseta-M) for relapsed/refractory...
US patent litigation targets single-cell sequencing IP
A Delaware jury found that Parse Biosciences, a subsidiary of Qiagen, willfully infringed three patents owned by Scale Biosciences (acquired by 10x Genomics in 2025) tied to methods for...
Company shutdowns and restructuring in biopharma
Bioxcel Therapeutics moved to sell substantially all assets and filed for Chapter 11 bankruptcy after evaluating strategic options earlier in 2026. The company’s process includes divestiture of...
Takeda earns rare blood disorder approval
The FDA approved rusfertide (Mimrylo) from Takeda and Protagonist Therapeutics for polycythemia vera, a rare blood disorder in which excess red blood cell production increases risk for...
Precision oncology: ADC development accelerates
CytomX’s fast track in metastatic colorectal cancer is one of multiple recent signals that ADC developers are pushing advanced programs toward earlier regulatory engagement. Varsetatug masetecan’s...
Immunotherapy innovation: CAR T reaches first-in-human autoimmune remission signals
Researchers at Charité—Universitätsmedizin Berlin reported early clinical-trial evidence that CD19 CAR T-cell therapy (mivocabtagene autoleucel) can bring severe, treatment-refractory seropositive...
Immunology & virology: HBV replication linked to innate immune switches
Multiple preclinical studies sharpen mechanistic maps of how innate immune proteins can suppress hepatitis B virus replication and transcriptional activity. Fujian Medical University reported that...
Genomics & AI for drug discovery: new prime-editing strategy
A Nature Biotechnology study reported a donor-matched prime-editing workflow designed to insert kilobase-scale DNA into the genome with more library-ready precision. The approach addresses a...
Regulatory approvals – diabetes cardiovascular benefit
Eli Lilly’s tirzepatide (Mounjaro) won FDA approval to reduce cardiovascular risk in adults with type 2 diabetes at high risk for cardiovascular events. The approval is based on SURPASS-CVOT, the...