China’s NMPA has granted marketing approval to eratrectinib (VC004), a next-generation TRK inhibitor developed by Nanjing-based Jiangsu Vcare PharmaTech Co., Ltd., for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions. The tumor-agnostic approval is notable for extending coverage to patients who have progressed on first-generation TRK inhibitors — a population for whom treatment options remain limited — and represents the first domestically developed next-gener

Two regimens containing Celcuity's multi-target PAM inhibitor gedatolisib halved the risk of disease progression or death versus Novartis' PI3Kα inhibitor Piqray (alpelisib) in adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer. The statistically significant and clinically meaningful findings come from the Phase III VIKTORIA-1 trial, which were presented Tuesday at the American Society of Clinical Oncology (ASCO) annual meeting

Emi-Le recently received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation Oral presentation shows Emi-Le was well tolerated and showed promising signals of efficacy among 45 evaluable participants with ACC June 1, 2026 -- Servier today announced promising new Phase 1 clinical data for Emi-Le, an investigational antibody drug conjuga

ZAYNICH is a multi- penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteria In the Phase 3 ENHANCE-1 clinical trial, ZAYNICH demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well tolerated More than 2.8 million an

June 1, 2026 -- SystImmune, Inc., a clinical-stage biotechnology company, today announced the oral presentation of Phase 1 data for BL-M14D1 in patients with small-cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), and other solid tumors (BL-M14D1-101, NCT06505824) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago. BL-M14D1 is a DLL3 targeting antibody drug conjugate being developed globally by SystImmune, a subsidiary of Biokin. This study evaluated the

Servier has agreed to acquire Edgewise Therapeutics' muscular dystrophy business for up to $2.65 billion, gaining control of the latter's late-stage candidate sevasemten. The move comes on the heels of the French drugmaker's roughly $2.5-billion takeout of Day One Biopharmaceuticals earlier this year. Monday's transaction includes $1.55 billion in upfront cash and as much as $1.1 billion in regulatory and commercial milestones. Expected to close in the third quarter, the deal transfers to Servi

The EGFR-NSCLC pipeline possesses some drugs in late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSP

BHV-8100 is an orally administered, brain-penetrant PKM2 modulator; a novel therapeutic class addressing the bioenergetic and immunometabolic basis of systemic and central nervous system disorders First-in-human study initiated with dose escalation ongoing; preliminary data in healthy participants demonstrates favorable pharmacokinetics supporting convenient, once-daily dosing and well a tolerated profile at projected therapeutic exposures Penetrates blood-brain barrier and reverses metabolic

Expanding in the metabolic space, Eli Lilly has struck a back-loaded licensing deal with South Korea’s Hanmi Pharm for a mid-stage GLP-2 agonist being trialed for short bowel syndrome. Eli Lilly’s late-spring dealmaking spree shows no sign of stopping as the pharma giant stuck a licensing agreement with South Korean biotech Hanmi Pharm worth up to $1.2 billion for access to a potential next wave of metabolic drugs. Under the deal, Lilly will help develop Hanmi’s Phase 2 GLP-2 agonist sonefpegl

Secretome Therapeutics, a clinical-stage biotechnology company developing novel therapies derived from neonatal cardiac progenitor cells (nCPC), today announced the closing of a $30 million Series A financing from RA Capital Management, LP (“RA Capital”), a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare, life sciences, and planetary health companies. RA Capital was the sole investor in the financing. The Series A financing will support comp