Latest Biotech News

The FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay, a dual DNA/RNA comprehensive genomic profiling test designed for solid tumors using formalin-fixed, paraffin-embedded tissue. The test...

Biogen advanced diranersen (BIIB-080) into registrational trials for early Alzheimer’s disease despite missing a key phase II primary endpoint, signaling that tau-pathology and biomarker effects...

A University of Queensland-led effort reported a precision strategy against drug-resistant bacteria that activates immune-cell mitochondrial fission, leveraging innate mechanisms rather than...

Shyld AI raised $13.4 million to expand its AI-powered UV disinfection platform that autonomously sanitizes hospital rooms. The company positioned the technology as a way to reduce...

Plans announced for five new proton therapy centers across Romania, Greece, Italy, Northern Ireland, and Poland aim to expand treatment capacity for patients across Europe. The initiative builds...

Bristol Myers Squibb and Hengrui Pharma signed a collaboration covering 13 early-stage programs in oncology, hematology, and immunology that could reach more than $15 billion in total value. Under...

FDA leadership is in flux after Marty Makary’s resignation, with Kyle Diamantas stepping in as acting commissioner. Multiple reports emphasized that the leadership transition is raising...

Researchers reported that serum extracellular vesicle N-glycomes can classify childhood epilepsy using a non-invasive biomarker approach. The work, published in Engineering, leverages N-glycan...

Regenxbio reported that its Duchenne muscular dystrophy gene therapy RGX-202 met a pivotal clinical bar, setting the stage for an FDA submission and accelerating the company’s path toward...

Create Medicines raised $122 million to expand its in vivo CAR-T platform, focusing on faster, one-day manufacturing using an mRNA-lipid nanoparticle approach to reprogram T cells, NK cells and...

FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling of solid tumors, enabling DNA and RNA testing on formalin-fixed, paraffin-embedded tissue. The...

Veristat launched InStat, an automated biostatistics platform designed to cut clinical trial data readout timelines from weeks to days. The company said the system can produce submission-ready...

AstraZeneca reported a Phase 3 win in bladder cancer using a combination built around Imfinzi. The company said combining Imfinzi with Pfizer’s Padcev improved outcomes versus standard of care,...

Multiple patent disclosures pointed to new small-molecule chemistry for both central nervous system and oncology targets. Vivozon reported new heterocyclic dual 5-HT2A/dopamine D2 receptor...

Fosun secured rights to AriBio’s oral Phase 3 Alzheimer’s therapy AR-1001 in a structured option deal that totals potential consideration of up to $4.7 billion, according to reporting. Fosun will...

Google-backed Isomorphic Labs closed a $2.1 billion Series B to scale its AI drug-design engine and expand toward the clinic. The company positioned the engine as a unified design-and-development...

Medicare expanded coverage for Personalis’ NeXT Personal minimal residual disease assay to include immunotherapy monitoring across late-stage solid tumors, following earlier coverage for...

A Spanish public-sector model aims to improve patient access to CAR-T therapy using hospital exemption manufacturing pathways, targeting faster delivery for eligible patients. Presenters described...

Create Medicines raised $122 million to expand its in vivo CAR-T platform targeting cancers and autoimmune indications, the company said. The Series B round was co-led by Arch Venture Partners,...

Bristol Myers Squibb and Hengrui Pharma agreed to collaborate across 13 early-stage programs spanning oncology, hematology, and immunology, with deal economics that could reach more than $15.2...