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Genome editing approval lands for hereditary angioedema
The FDA has approved Intellia Therapeutics’ in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) following clearance of the company’s biologics license application, delivering a one-dose genome...
Sanofi and Regeneron expand long-acting immunology push beyond Dupixent
Sanofi is deepening its long-standing antibody partnership with Regeneron by funding four next-generation long-acting immunology candidates in a deal structured around an $1 billion upfront...
US launches simulation-augmented trial framework to speed clinical development
The US Department of Health and Human Services announced new programs intended to accelerate clinical trial timelines as competition for study execution intensifies from regions such as China and...
Major immunotherapy safety signal emerges from global drug safety databases
Immune checkpoint inhibitors have been linked to a rare platelet disorder, according to a report drawing on two global drug safety databases. The finding spotlights a new type of immune-related...
New real-world evidence for a leukemia BTK inhibitor in China
Zanubrutinib is showing favorable real-world performance in a nationwide Chinese analysis covering 410 patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), adding...
AI boosts precision oncology workflows by reading H&E slides
A team in China has developed RIDGE, an AI system that predicts cancer molecular biomarkers directly from routine hematoxylin and eosin (H&E) pathology slides. The approach aims to translate...
Trial data feed into next-gen obesity pipeline as Regeneron reports muscle regain signals at EASD
At EASD26 in Milan, Regeneron presented data suggesting its antibody maintained clinically meaningful muscle-related outcomes in obesity patients who stopped Novo Nordisk’s Wegovy, with results...
New health-tech funding supports AI patient outreach automation
Parakeet Health, a startup automating patient communications for scheduling and follow-ups, raised $10 million to expand outreach workflows that connect patients to appointments and...
Neuroscience-imaging innovation targets seizure risk stratification in gliomas
Researchers report that brain scan tracer uptake patterns can help identify which slow-growing diffuse lower-grade gliomas are more likely to trigger seizures. The work focuses on a practical...
Space manufacturing gets major capital for drug production in orbit
Varda Space Industries announced a $251 million Series D to advance pharmaceutical manufacturing in space, continuing a wave of investment into orbital platforms intended to support new ways of...
Sanofi and Regeneron expand long-acting immunology pipeline
Sanofi and Regeneron expanded their long-standing antibody alliance with a new deal worth up to $8 billion, centered on developing next-generation long-acting immunology drugs that build on the...
HHS launches SURPASS and ARPA-H initiatives to speed clinical trials
The U.S. Department of Health and Human Services unveiled new programs designed to speed and modernize clinical development, citing intensifying global competition and operational bottlenecks that...
Hibernating hamsters reveal histone rewiring during torpor
New research highlights how Syrian hamsters survive winter torpor by changing chromatin structure without rewriting their DNA sequence. The study focuses on histone modifications that help cells...
Regulatory turnaround attempt: Atara and Pierre Fabre resubmit Ebvallo
Atara Biotherapeutics and Pierre Fabre Pharmaceuticals said they have resubmitted to the FDA for Ebvallo (tabelecleucel) after earlier rejections, as the partners seek approval for a...
Lilly exits Foghorn synthetic lethality collaboration
Eli Lilly is ending its collaboration with Foghorn Therapeutics in synthetic lethality, according to the latest reporting that the biotech has cut headcount by 40% after the partnership was culled...
AbbVie’s zuilokibart moves toward Phase 3 in atopic dermatitis
AbbVie is progressing zuilokibart—an antibody acquired through its Apogee deal—into Phase 3 evaluation for atopic dermatitis, as competitors continue to push long-acting and targeted...
Invivyd posts Phase 3 safety results for low-dose Covid antibody VYD2311
Invivyd reported Phase 3 LIBERTY results showing its low-dose monoclonal antibody VYD2311 was better tolerated than Pfizer’s Comirnaty mRNA vaccine in a head-to-head safety and tolerability...
Genomics and diagnostics: TB-Profiler upgrade uses 171,000 genomes
TB-Profiler received a major upgrade that expands its genomic reference capacity to improve drug-resistance prediction. The tool’s newest version incorporates 171,000 genomes to sharpen...
Clinical development: triGemX Bio targets migraine with Phase 3 program after rebrand
Kallyope rebranded as TriGemX Bio and shifted focus exclusively to migraine, after a Novo obesity-related deal prompted corporate restructuring. The company said it will support and advance its...
Venture and health operations: Parakeet Health raises $10M for automated patient outreach
Parakeet Health raised $10 million to automate patient outreach and scheduling workflows using AI-driven communications. The startup uses tools that can call, text and email patients to schedule...