Latest Biotech News

Sanofi halted its Phase 3 MOBILIZE study of riliprubart in chronic inflammatory demyelinating polyneuropathy after an independent monitoring board concluded the drug was unlikely to achieve...

A Chinese research team reported safety and feasibility for a subretinal AAV8 gene therapy delivering an RS1 transgene to photoreceptors in pediatric X-linked retinoschisis (XLRS). Published in...

Researchers at UT MD Anderson and collaborators published results in Nature Biomedical Engineering showing skeletal-muscle-targeted non-viral delivery of full-length DMD mRNA in a murine model....

Laekna is monetizing an oncology asset by licensing ex-China rights to LAE-118, a PI3Kα pan-mutant selective inhibitor, to U.S.-based Vasque Bio in a deal valued at up to $527 million. The...

OraSure Technologies won FDA 510(k) clearance for its Colli-Pee urine sample collection kit enabling at-home self-collection followed by molecular STI testing on Roche systems. The cleared...

A new AI system from researchers in Heidelberg classifies brain tumors from standard histological tissue sections in minutes, using deep learning on conventional stains rather than specialized...

Parabilis Medicines priced a record-setting $670 million biotech IPO on Nasdaq, surpassing prior large listings this year. The cancer-focused company priced 3.5 million shares at $20 per share and...

SonoThera raised $125 million in a Series B to advance an ultrasound-based, microbubble-mediated non-viral delivery platform for genetic medicines. The company’s technology uses microbubbles...

Researchers introduced a benchmarking study assessing how large language models can be used in RNA biomarker discovery for cell-free RNA (cfRNA) diagnostics, aiming to improve reproducibility and...

Sanofi moved to stop its Phase 3 MOBILIZE trial of riliprubart in chronic inflammatory demyelinating polyneuropathy after an interim analysis found the antibody was unlikely to provide sufficient...

GSK agreed to acquire Nuvalent for $10.6 billion, adding near-commercial and clinical-stage targeted programs for NSCLC. The deal brings zidesamtinib (NVL-520) and eladalkib (NVL-655), both...

A Chinese research team reported safety and feasibility of a subretinal AAV8 gene therapy delivering a codon-optimized RS1 transgene for pediatric X-linked retinoschisis (XLRS), with results...

SonoThera raised $125 million to advance its ultrasound-based, microbubble-mediated non-viral gene delivery platform into clinical development. The financing is intended to propel lead programs in...

OraSure Technologies received FDA 510(k) clearance for an at-home urine sample collection kit for sexually transmitted infection (STI) testing on Roche systems. The Colli-Pee kit supports...

Kardigan filed for a Nasdaq IPO targeting net proceeds around $320 million, as the cardio-focused company prepares Phase 2b/3 and Phase 2 studies across genetic dilated cardiomyopathy and calcific...

Sensorion ended development of its OTOF-related hearing loss gene therapy program, citing a strategic review that found the development environment had “notably changed.” The decision follows...

Merck and Gilead reported that a combination of Merck’s islatravir and Gilead’s lenacapavir met primary efficacy endpoints in two Phase 3 trials evaluating a weekly oral HIV regimen for people who...

Lilly agreed to receive $10 million upfront plus milestones and royalties in a licensing and collaboration deal with AlzeCure for gamma-secretase modulator ACD680, bringing Lilly deeper into...

A new industry analysis highlights how revised EU manufacturing guidelines are pushing drug developers toward stronger in-process assurance for sterile filtration. The focus is on PUPSIT (pre-use...

GSK agreed to acquire Nuvalent for $10.6 billion, adding two near-commercial non-small cell lung cancer (NSCLC) programs to its pipeline and positioning the company for potential approvals later...