Latest Biotech News

Egetis Therapeutics secured FDA approval for tiratricol, branded emcitate, for certain patients with an X-linked genetic disease, the company said Monday. The approval covers a population with...

Merck closed an exclusive global licensing deal with China-based SciBrunch Therapeutics for an early KRAS G12D program, according to multiple reports. The agreement includes $400 million upfront...

Kodiak Sciences reported a Phase 3 “Daybreak” success showing noninferior vision outcomes versus Regeneron’s Eylea (aflibercept) for both tarcocimab tedromer (Zenkuda) and the anti-IL-6/VEGF-trap...

Mirum Pharmaceuticals reported back-to-back developments for its hepatitis delta virus (HDV) strategy: U.S. FDA approval of once-daily, oral ALK2 inhibitor Atebrioz (zilurgisertib) for...

The FDA approved AbbVie’s oral Parkinson’s therapy Juvmo (tavapadon), a selective D1/D5 receptor agonist and first-in-class dopamine D1/D4 partial agonist, the company said. The approval extends...

Adicet Bio reported early clinical signals for prula-cel, an off-the-shelf CAR-T approach, in a lupus trial, with the company stating that a subset of patients achieved complete kidney responses...

Daiichi Sankyo and Merck voluntarily withdrew their BLA for ifinatamab deruxtecan (i-dxd) targeting B7-H3 in extensive-stage small-cell lung cancer after FDA pushback on the evidentiary basis for...

Market attention sharpened on Kodiak’s wet AMD strategy after Phase 3 results showed that Zenkuda and KSI-501 met primary endpoints versus Eylea in the Daybreak study, with dosing...

Nutshell Therapeutics (Shanghai) received FDA IND clearance for NTS-231, a covalent allosteric molecular glue degrader of NRF2 designed to induce KEAP1-dependent NRF2 degradation. The company said...

Veeva Systems unveiled Study Builder, an agentic AI tool intended to accelerate clinical trial study configuration for sponsors using existing EDC and data quality workflows. The technology...

Merck closed a large licensing agreement with China’s Scibrunch Therapeutics for an oncology candidate targeting KRAS G12D, paying $400 million upfront with development and commercialization...

Kodiak Sciences reported Phase 3 success for two wet age-related macular degeneration programs, targeting Eylea (aflibercept) with individualized dosing strategies. The company said tarcocimab...

Mirum Pharmaceuticals reported Phase 3 “victory” in chronic hepatitis delta, building momentum after its acquisition of the program. The company said more than half of patients treated with a...

Researchers at Washington University School of Medicine in St. Louis reported preclinical data showing that blocking CXCR3 can reduce T-cell infiltration and limit neurodegeneration in a mouse...

Adicet Bio reported early clinical evidence that its off-the-shelf CAR-T approach, prula-cel, can induce complete kidney responses and remission in lupus nephritis patients. After one year of...

Daiichi Sankyo and Merck withdrew their BLA for ifinatamab deruxtecan in extensive-stage small-cell lung cancer after FDA feedback, according to the report. The companies said they voluntarily...

Nutshell Therapeutics received FDA IND clearance for NTS-231, a covalent allosteric molecular glue degrader designed to induce NRF2 degradation by covalently binding KEAP1. The company said the...

Vasomune Therapeutics completed enrollment in its Phase 2a trial of pegevongitide (AV-001) for patients hospitalized with pneumonia requiring supplemental oxygen. The randomized, double-blind,...

Scynexis secured a new Biomedical Advanced Research and Development Authority (BARDA) contract worth $214 million to develop SCY-247 for invasive fungal infections. The agreement expands the...

Veeva unveiled an AI agent designed to speed clinical trial study configuration for its EDC and Data Quality System customers. Veeva said Study Builder ingests a study protocol and, using agentic...