First Targeted Therapy Approved for NRG1+ Cholangiocarcinoma BIZENGRI Now Approved for Patients Harboring NRG1 Gene Fusions in Non-small Cell Lung Cancer, Pancreatic Adenocarcinoma, and Cholangiocarcinoma May 11, 2026 -- Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIZENGRI® (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarci

Drug developers are racing to make gene therapies that could replace chronic GLP-1 injections and pills with a one-and-done treatment. Now, a company based just outside of Boston is poised to become the first to start a clinical trial of the potentially permanent approach. Fractyl Health has received clearance from European regulators to begin testing its gene therapy in the Netherlands, the company told Endpoints News. The treatment should allow people with type 2 diabetes to make more GLP-1 p

While regulatory reviews are under way in the US, EU and Japan, it is China that is seen as a key market if GSK is to achieve sales targets for its hepatitis B therapy bepirovirsen. And in an effort to realise these ambitions, the UK drugmaker on Monday announced a deal with Sino Biopharmaceutical and its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ). "By combining GSK's innovation with CTTQ's extensive local scale and execution, we want to reach more patients, deliver greater impact, and

May 11, 2026 -- PulseSight Therapeutics SAS, an ophthalmology clinical stage biotech company developing disruptive non-viral vectorized gene therapies with minimally-invasive delivery technology, has reported the results of its PST-611 Phase 1 clinical trial (PST-611-CT1), in patients with late-stage dry Age-related Macular Degeneration (AMD) called Geographic Atrophy (GA), in a podium presentation at the ARVO 2026 Annual Meeting. GA is a multifactorial disease involving a dysregulation of iron

May 10, 2026 -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2α-bias

IND submitted to initiate Phase 3 PANDA diagnostic trial in the U.S. in hypertension with underlying primary aldosteronism First-in-class PET/CT imaging enabling treatment decisions through non-invasive subtype differentiation Strong market opportunity driven by underdiagnosis and increasing need for precision diagnostics in primary aldosteronism May 11, 2026 / Pentixapharm Holding AG (Frankfurt Prime Standard:PTP), a clinical-stage biotech developing novel radiopharmaceuticals today announced

May 8, 2026 -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Investigational New Drug (IND) application for 9MW5211, its independently developed novel antibody, has received clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical studies for the treatment of inflammatory bowel disease (IBD). Clinical trial applications for multiple indications including IBD and multiple sclerosis (MS

May 8, 2026 -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, today announced that it will host a live webcast presentation on Monday, May 11, 2026 at 5:30 a.m. Pacific Time to provide interim results from the randomized, first-line Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combina

May 9, 2026 -- Recently, the novel oral BET inhibitor NHWD-870 HCI, independently developed by Zhejiang Wenda Pharmaceutical Technology Co., Ltd., officially received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the proposed indication of advanced thoracic midline (NUT) carcinoma in patients who have failed prior chemotherapy. This milestone progress brings new targeted therapy hope to NUT carcinoma patients, a disease with extremely high ma

On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy. This application is part of the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which is