Latest Biotech News

The FDA cleared OraSure Technologies’ at-home urine sample collection workflow for sexually transmitted infection testing using Roche systems, expanding convenient specimen collection tied to...

SonoThera advanced non-viral ultrasound-mediated gene delivery with a major Series B that raised $125 million, aiming to move its platform into clinical development. The financing targets two lead...

Novartis’ takeover-driven dystrophy asset gained momentum after the Swiss drugmaker posted phase 1/2 success tied to regulatory discussions for its dystrophy program from the Avidity Biosciences...

A melanoma immunology study mapped a key immune microenvironment interaction by showing how tumor-resident T cells and dendritic cells coalesce into a distinct functional unit. The Nature...

Kardigan prepared to bring three late-stage cardiac assets to the public markets with a planned $320 million Nasdaq IPO, funded in part by a cardiovascular leadership team with ties to prior...

Sanofi stopped its phase 3 MOBILIZE trial of riliprubart in chronic inflammatory demyelinating polyneuropathy after an independent monitoring committee judged the study unlikely to provide...

GSK agreed to acquire Nuvalent for $10.6 billion, a multi-asset deal aimed at strengthening GSK’s oncology pipeline with precision NSCLC therapies. Two programs are under FDA review—zidesamtinib...

T-Curx won Swissmedic approval for a first-in-human phase I study of TCX-001, a Siglec-6-targeted nonviral CAR T program. The trial will enroll adults with relapsed or refractory AML and CLL,...

A diagnostics and digital pathology advance focused on how foundation models can be engineered for robustness in clinical microscopy workflows. Researchers described a foundation-model approach...

Guardant Health said the FDA has approved its Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The...

Takeda said its oral TYK2 inhibitor zasocitinib outperformed Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 trial for plaque psoriasis. Takeda reported statistical superiority across...

A Chinese team reported safety and feasibility for a subretinal AAV gene therapy delivering an RS1 transgene to photoreceptors in pediatric X-linked retinoschisis. Published in the New England...

SonoThera raised an oversubscribed $125 million Series B to push its ultrasound-mediated genetic medicine platform into clinical development. The funding supports lead programs in Duchenne...

GSK agreed to acquire Nuvalent for $10.6 billion, positioning the deal to strengthen its precision oncology portfolio in ROS1- and ALK-driven NSCLC. Nuvalent’s pipeline includes zidesamtinib...

Parabilis priced an upsized $670 million IPO on Nasdaq, marking the largest-ever biotech listing from a venture-backed company. The company sold 33.5 million shares at $20 each, and also disclosed...

Researchers reported systemic delivery of full-length DMD mRNA using skeletal-muscle-targeted extracellular vesicles in a murine Duchenne model. The study, published in Nature Biomedical...

Sciwind said it has licensed its GLP-1 obesity drug ecnoglutide to Pfizer and Verdiva Bio, while indicating it remains open to additional partners for the remaining rights it holds. The company’s...

T-Curx obtained Swissmedic approval for a first-in-human Phase I study of TCX-001, a Siglec-6-targeted nonviral CAR T program. The trial will open in Switzerland with plans to expand to Germany...

HKU and NICE signed an MoU intended to strengthen Hong Kong–Yangtze River Delta collaboration on innovation, applied research, commercialization, and talent development. The agreement, announced...

GSK agreed to acquire Nuvalent for $10.6 billion, aiming to bolster its oncology pipeline with next-generation kinase inhibitors in NSCLC. The deal includes zidesamtinib (ROS1) and eladalkib...