Latest Biotech News

The FDA finalized clinical guidance for psychedelic drug developers and scheduled a public hearing on future therapeutic use, signaling that regulators are moving from research-stage oversight...

GSK said Jemperli (dostarlimab) met the primary goal in an AZUR-1 phase 2 study in dMMR/MSI-H locally advanced rectal cancer, setting up an FDA submission with the company targeting an accelerated...

A new study in liver cancer describes how Nrf2—known as a metabolic master regulator—helps drive accumulation of regulatory T cells (Tregs) in hepatocellular carcinoma. By linking metabolic...

Researchers reported a CAR-Treg approach engineered to block soluble pollen-derived allergens, aiming to control inflammation in an antigen-specific way. The strategy targets immune regulation...

UCL Great Ormond Street researchers built a laboratory model of infant lungs using pediatric airway cells, blood vessel cells, and neutrophils to study why RSV is more severe in babies than in...

Circular Genomics is collaborating with ophthalmic imaging startup Vitazi.AI to clinically validate a retinal-scan “oculomics” approach alongside its circular RNA biomarker platform for early...

JaxBio, an Israeli diagnostics firm, is expanding access to DNA methylation-based liquid biopsy testing using a hybridization microarray-based platform. The company’s focus starts with lung cancer...

The World Heart Federation released a Roadmap on cardiac rehabilitation, aiming to strengthen secondary prevention as heart disease burden rises alongside aging populations. The framework is...

MindRank AI raised a $52 million Series B to advance MDR-001, an AI-discovered oral GLP-1 receptor agonist in phase III development in China for obesity. The company said the round will support...

Q32 Bio reported that bempikibart (bempi) hit the Phase 2 main goal in alopecia areata, with two-fifths of patients reaching a hair-covering threshold after 36 weeks. Investors reacted strongly to...

Cyllene Therapeutics secured a $37 million Series C to push EG110A into late-stage development for severe neurogenic bladder. The financing is earmarked for advancing the company’s lead gene...

MindRank raised $52 million in Series B funding to advance MDR-001, its oral GLP-1 candidate, with Phase III in China already underway. The company said the money will scale its AI-native Molecule...

A watchdog group warns that the FDA’s shift toward “one pivotal trial” approval pathways could increase the risk of ineffective drugs reaching market. In a Center for Science in Public Interest...

A global Alzheimer’s research push is using open proteomics and AI-enabled discovery to profile large plasma datasets as researchers look for improved detection of Alzheimer’s and related...

A JAMA case report connected amyloid clearance to downstream neuropathologic change after amyloid-targeting therapy in Alzheimer’s disease. The report described cases where regions showing...

China Medical System Holdings (CMS) expanded its AI collaboration with Insilico Medicine, targeting CNS disorders with a new agreement framed around a “mass-market” indication. The collaboration...

The FDA released 14 new drug rejection letters after a three-month pause in a transparency policy for publishing those documents. The publication follows the agency’s confirmation to Fierce that...

Alliance Foundation Trials reported that weekly electronic symptom monitoring improved quality of life for patients receiving treatment for advanced cancer. Published in JCO Oncology Practice, the...

Neurovalens received FDA de novo approval for Modius Spero, a wearable neuromodulation device for PTSD treatment for U.S. veterans through the Department of Veterans Affairs. The at-home therapy...

As biopharma earnings season kicks off, market attention is turning to whether deal activity stays strong after the first half of 2026. The report characterizes busy M&A as setting the tone for...