Latest Biotech News

GSK has reported a main-goal win in a pivotal Phase 2 rectal cancer study and is now positioning Jemperli for an FDA submission under an accelerated pathway. In the AZUR-1 trial, the PD-1...

Biogen’s tau-directed Alzheimer's program drew new attention as mid-stage results showed slower decline on multiple measures, with the strongest signal appearing in the lowest dose arm. Across 18...

Cellares and Sonoma Biotherapeutics announced they will automate manufacturing for SonomaBio’s engineered Treg cell therapy SBT-77-7101 as the program advances in Phase I for poly-refractory...

Roche’s decision to end development of tominersen in Huntington’s disease is sharpening the competitive read-through for Wave Life Sciences’ allele-selective antisense oligonucleotide strategy....

Draig Therapeutics raised $65 million in an oversubscribed Series B to advance a neuropsychiatry pipeline led by a depression program designed to modulate the AMPA receptor. The company said the...

The FDA moved toward a streamlined system for drug establishment registration as it looks to simplify how factory registrations are handled for products made for the U.S. market. In a proposal...

Researchers reported a metabolic mechanism that appears to promote regulatory T-cell accumulation in hepatocellular carcinoma, positioning Nrf2 as a driver of immune evasion. In the study, Nrf2...

Circular Genomics said it is testing whether retinal imaging risk stratification—an “oculomics” approach—can improve the performance of its circRNA-based Alzheimer's screening and progression...

Ceperognastat, an oral small-molecule inhibitor targeting OGA (O-linked N-acetylglucosaminidase), failed to show a measurable clinical impact in a JAMA trial evaluating early symptomatic...

Cyllene Therapeutics secured a $37 million Series C to advance EG110A for late-stage development in severe neurogenic bladder. The financing is intended to move the lead candidate closer to...

GSK moved closer to an FDA filing for Jemperli after AZUR-1 Phase 2 results in a small but high-stakes rectal cancer subgroup. The company said Jemperli (pd-1 inhibitor) met the main goal, with a...

Innovent Biologics agreed to a major pivot deal with Spero Therapeutics, signaling a shift away from its GSK-owned antibiotic focus and toward immune and inflammation indications. The arrangement...

Q32 Bio reported new Phase 2 results for bempikibart (IL-7Rα inhibitor) in severe alopecia areata, and investors responded immediately. In part B of the SIGNAL-AA study, the company said...

A STAT+ write-up highlighted how AI progress in drug development may be running ahead of practical expectations in drug metabolism. The piece pointed to competition results suggesting that bigger...

The FDA advanced a proposed rule aimed at simplifying drug establishment registration for factories supporting the U.S. market. The rule is designed to streamline how regulated manufacturing sites...

The UK is setting up a nationwide dementia registry designed to accelerate clinical trial recruitment while collecting real-world evidence once therapies are approved. The approach centers on...

Circular Genomics is exploring how retinal imaging-based “oculomics” could improve Alzheimer’s risk stratification alongside its circRNA biomarker platform. The company said it is collaborating...

Neurovalens received FDA de novo clearance for Modius Spero, a wearable neuromodulation device for at-home therapy targeting PTSD symptoms in U.S. veterans. The agency authorization enables use...

A new strategy reported engineered CAR Tregs to counter birch pollen allergy by directing cell therapies against soluble allergens. The approach focuses on controlling immune inflammation through...

Germany’s parliament approved healthcare reforms that raise mandatory rebates on branded medicines from 7% to 15.5%, despite pharma and industry group pushback. Lawmakers also cleared additional...