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

New company (“NewCo”) co-founded by Nxera with a syndicate of leading healthcare and life sciences-focused investment firms. In return for granting an exclusive worldwide license to the program, Nxera is eligible to receive up to US$275 million in development and commercial milestone payments as well as tiered royalties. In addition, Nxera retains rights to Japan and certain Asia-Pacific territories and now holds a significant minority equity stake in the NewCo. Builds toward the establishment

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

Eli Lilly’s latest manufacturing expansion will support production of obesity blockbusters and next-gen assets, while the new Lilly Lebanon Advanced Therapies site will take experimental genetic medicines from research to commercialization. Eli Lilly is pouring $4.5 billion into two manufacturing sites in its home state, including its newly opened Lilly Lebanon Advanced Therapies, the pharma’s first dedicated genetic medicine building. The site is designed to produce a range of genetic therap

LenioBio GmbH, a TechBio company commercializing its ALiCE® cell-free protein expression platform, today announced a collaborative agreement with Twist Bioscience Corporation. The collaboration will integrate our ALiCE® platform with Twist’s DNA manufacturing and automation capabilities to accelerate the design–build–test cycle for protein expression services—delivering experimental results back to customers’ and partners’ AI models faster. “AI can design new protein molecules for biologic drug