Latest Biotech News

Akeso’s ivonescimab, a PD-1/VEGF bispecific, reduced the risk of death by 34% versus a PD-1 inhibitor–chemotherapy comparator in a Phase 3 study in China for previously untreated advanced squamous...

Autobahn Therapeutics said the FDA granted Fast Track status to elunetirom (ABX-002), an investigational oral small molecule prodrug designed to activate CNS thyroid hormone receptors as an...

Rallybio agreed to merge with Avenzo Therapeutics in a new reverse merger after a previous Candid Therapeutics deal was derailed by UCB’s $2 billion buyout. Under the agreement, Avenzo...

A report on China’s new cell and gene therapy (CGT) rules says the regulatory update could change how developers structure trials, manufacturing, and commercial planning for CGT products in the...

Eli Lilly licensed Hanmi Pharma’s long-acting GLP-2 agonist sonefpeglutide for short bowel syndrome, paying $75 million upfront with up to $1.185 billion more tied to clinical, regulatory, and...

Interim data from SWOG S1823/GCC suggest microRNA-371a-3p (miR371) can predict relapse risk in early-stage germ cell malignancy under active surveillance, though the study authors emphasize that...

Replimune said it will resubmit its biologics license application for RP1, its melanoma therapy, shortly after prior FDA rejections in July 2025 and April. The company linked the timing to...

A healthcare and life sciences IPO market update says biotech dealmaking and listing activity is strengthening in 2026, but investors continue to demand high-quality data and differentiated...

Revolution Medicines’ daraxonrasib posted detailed, phase 3 results at ASCO that investigators described as practice-changing in metastatic RAS G12-mutant pancreatic cancer. In the trial...

Akeso’s ivonescimab delivered a 34% overall survival improvement in an interim analysis of the China-based phase 3 Harmoni-6 trial, presented at ASCO. In previously untreated advanced squamous...

Replimune is preparing a third regulatory submission for its melanoma therapy RP1 after the FDA leadership shakeups that surrounded prior review cycles. The company said it will resubmit its...

A new phase 3 hormone-regimen strategy around surgery showed signals of improved outcomes in high-risk early prostate cancer at ASCO. J&J’s Erleada (apalutamide) reduced the risk of metastasis or...

Eli Lilly agreed to license Hanmi Pharm’s phase 2-stage GLP-2 agonist sonefpeglutide for short bowel syndrome, extending Lilly’s push beyond traditional weight-loss chemistry into gastrointestinal...

The FDA granted Fast Track designation to Autobahn Therapeutics’ elunetirom (ABX-002) for adjunctive treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults....

Pfizer struck a back-heavy cancer collaboration with China’s Innovent Biologics to build a pipeline of 12 antibody-based therapies across multiple oncology indications. Pfizer will pay $650...

ASCO will not recommend Grail’s Galleri multi-cancer early detection test for inclusion in cancer screening guidelines after reviewing data from a large prospective randomized trial. The...

In a prospective SWOG S1823/GCC cohort study, researchers reported that microRNA 371a-3p can identify relapse risk in early-stage testicular cancer, though the clinical utility of the biomarker...

Eli Lilly’s $3.2 billion acquisition of Kelonia Therapeutics draws on new data for an in vivo CAR-T approach. Coverage highlighted an “in vivo CAR-T” dataset with a reported 100% response rate as...

Replimune said it will resubmit its biologics license application for RP1 in advanced melanoma in the coming days, marking the therapy’s third attempt after two FDA rejections. The company is...

Pfizer struck a back-heavy collaboration with Innovent Biologics to build a pipeline of antibody-based cancer therapies spanning 12 early-stage assets. The deal, announced with an expected close...