Latest Biotech News

The FDA issued another complete response letter to Camurus for Oclaiz (CAM-2029) in acromegaly, marking a repeat rejection tied to the subcutaneous extended-release octreotide program. The CRL...

Takeda reported that its oral TYK2 inhibitor zasocitinib (investigational) outperformed Bristol Myers Squibb’s Sotyktu (deucravacitinib) in a head-to-head Phase 3 psoriasis program, showing...

A Chinese team reported safety and feasibility of a subretinal gene therapy for X-linked retinoschisis (XLRS) in a dozen pediatric patients, with results published in the New England Journal of...

Researchers published new non-viral delivery data for Duchenne muscular dystrophy (DMD) that target skeletal muscle and deliver full-length DMD mRNA systemically. The platform uses allogenically...

Japan’s pharma and CRO ecosystem lacks clear governance for generative AI use in clinical trials, according to a new study surveying industry participants. Researchers found that only 60% of...

Parabilis priced an upsized $670 million IPO on Nasdaq, setting a new record for biotech initial public offerings. The oncology-focused company priced at $20 per share after earlier plans and is...

Buzz Health reported a behavioral threshold for prescription abandonment: when out-of-pocket costs rise to $35, fill rates drop sharply. The study found 89% of respondents would fill at a $15...

Regulators prepared trials in the Democratic Republic of the Congo and Uganda for Bundibugyo Ebola vaccines and therapeutics, as the outbreak continues to evolve. The plan includes testing...

OraSure Technologies received 510(k) clearance from the FDA for an at-home urine sample collection kit compatible with Roche molecular systems for STI testing. The Colli-Pee kit supports...

China’s NMPA has greenlit Suzhou Alphamab’s HER2 bispecific anbenitamab (KN-026) for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma...

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...