Latest Biotech News

ADC Therapeutics said its Phase III confirmatory trial for loncastuximab tesirine (Zynlonta) ran into a safety stumbling block after reporting higher fatalities in the treatment arm of LOTIS-5....

UniQure said the FDA reversed course again on its Huntington’s disease gene therapy AMT-130, clearing the company to submit for accelerated approval in the third quarter. The latest U-turn follows...

F2G and Shionogi reported positive Phase III data for olorofim, positioning the oral antifungal for a potentially clear approval route. The companies said the drug performed as well as an existing...

Kardigan raised $400 million in an IPO aimed at supporting three clinical-stage cardiovascular drugs. The offering contributes to a buoyant IPO environment for biotech in 2026, with the company...

Biogen agreed to pay as much as $1 billion to acquire RayThera, a San Diego biotech that has disclosed limited pipeline detail since launching last year. The transaction is structured...

The FDA extended the comment period for its real-time clinical trial (RTCT) pilot covering how AI can be used to report endpoint data during early-phase studies. The agency pushed the deadline to...

A new regulatory track in China has taken effect that allows certain advanced biomedical technologies—including select gene editing treatments, personalized cell therapies, and...

Researchers published a multimodal, multitask deep learning system for grading management in non-small cell lung cancer (NSCLC), reported in Nature Communications. The approach integrates multiple...

Gan & Lee Pharmaceuticals reported positive Phase III data for two metabolic programs—its once-weekly basal insulin candidate Ludefen and obesity therapy bofanglutide—signaling renewed momentum...

The FDA reversed course on uniQure’s Huntington’s disease program AMT-130, clearing the way for the company to submit for accelerated approval. uniQure said it can file in the third quarter after...

ADC Therapeutics’ Zynlonta (loncastuximab tesirine) hit a major clinical snag after confirmatory Phase III results for LOTIS-5 showed higher fatality rates in the treatment arm. The study met its...

F2G and Shionogi reported positive Phase III data for olorofim, an oral antifungal being developed for invasive aspergillosis. The companies said the trial met its primary comparison, setting up a...

The US FDA extended the comment period for its real-time clinical trial (RTCT) pilot focused on AI-assisted reporting of endpoints during early-stage studies. In a Federal Register notice, the...

JAMA published results from the HARMONi-A randomized clinical trial assessing ivonescimab combined with chemotherapy in EGFR-variant non–small cell lung cancer. The report adds to the evidence...

Kardigan extended the sector’s IPO run by raising $400 million ahead of its Nasdaq debut. The cardiology drug developer, which has three clinical-stage programs, priced an offering tied to the...

Merck & Co. launched a multi-target AI drug discovery collaboration with Protillion Biosciences, with potential milestone payments up to $510 million. The partnership is built around Protillion’s...

Jazz Pharmaceuticals agreed to a preclinical research collaboration with AbCellera to discover next-generation T-cell engaging multispecific antibodies targeting gastrointestinal cancers and other...

Researchers used tissue and liquid biopsy data to identify DNA methylation subgroups in pleural mesothelioma that may predict outcomes on standard immunotherapy regimens. The work, published in...

GLP-1 weight-loss competition remains the center of attention as pharma players continue to push new offerings to compete with Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, according to STAT’s...

F2G and Shionogi reported positive Phase 3 results for olorofim, their oral antifungal targeting invasive aspergillosis. The companies said the study met its primary non-inferiority objective...