Latest Biotech News

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...

Revolution Medicines presented additional details from its Phase 3 pancreatic cancer study featuring daraxonrasib at ASCO, with investigators describing results as “landscape-changing.” In the...

Revolution Medicines began shipping daraxonrasib to physicians and patients under an early access program authorized by the FDA, CEO Mark Goldsmith said during an ASCO-linked briefing. The therapy...

Akeso and Summit reported overall survival results showing their PD-1/VEGF bispecific ivonescimab plus chemotherapy reduced the risk of death by 34% versus PD-1 inhibitor plus chemo in previously...

Eli Lilly licensed Hanmi Pharm’s Phase 2-stage GLP-2 agonist sonefpeglutide for short bowel syndrome, expanding Lilly’s gastrointestinal pipeline. Under the agreement, Lilly will pay $75 million...

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....

Puxitatug samrotecan (AZD8205) produced high response rates in B7-H4-expressing recurrent or progressive endometrial cancer in the Phase 1/2a BLUESTAR study, supporting an FDA Breakthrough Therapy...

Signos secured $20 million to expand its glucose monitoring platform beyond diabetes and into weight loss. The approach combines Dexcom’s over-the-counter CGM offering with a software app that...

Evaluate’s orphan drugs report projects that orphan drugs will account for more than 21% of all prescription pharmaceutical sales by 2032, up from 15% in 2022. The analysis also forecasts rare...

Replimune moved to a third attempt for RP1 in advanced melanoma after the FDA’s rejection history and recent leadership turnover at the agency. The company said it will resubmit its biologics...

Revolution Medicines’ daraxonrasib delivered broadly strong survival and disease-control results in metastatic pancreatic cancer, with detailed interim data presented at ASCO. In the Phase 3 trial...