– EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options – Lung cancer remains the leading cause of cancer-related deaths throughout the world 1 NORTH CHICAGO, IL, USA I May 14, 2025 I AbbVie (NYSE: ABBV) today announced that EMRELIS ™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S. Food and Drug Administration (FDA) for t

SOUTH SAN FFRANCISCO, CA, USA and BAGSVAERD, Denmark I May 14, 2025 I Septerna, Inc. (Nasdaq: SEPN) and Novo Nordisk today announced an exclusive global collaboration and license agreement to discover, develop and commercialise oral small molecule medicines for obesity, type 2 diabetes and other cardiometabolic diseases. The companies will initially commence four development programmes for potential small molecule therapies directed to one or more select G protein-coupled receptor (GPCR) targets

WILMINGTON, DE, USA I May 15, 2025 I Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz ® (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). In addition, the FDA granted approv

– PBGENE-DMD is a first-in-class in vivo gene editing approach for the majority of Duchenne Muscular Dystrophy patients impacted by dystrophin mutations in the most common ‘hot spot’ region between exons 45-55 – – Final clinical candidate PBGENE-DMD demonstrates compelling preclinical data for durably improving functional benefit over time – – Precision targeting to submit an Investigational New Drug (IND) and/or Clinical Trial Application (CTA) for PBGENE-DMD in 2025 with clinical data expected

HERLEV, Denmark, May 16, 2025 /PRNewswire/ -- Nordic Bioscience introduces nordicEndotrophin™, a fully automated high-precision assay that selectively quantifies the intact 77-amino-acid Endotrophin signaling hormone—qualified in the CAP/CLIA certified Nordic Bioscience laboratory. When integrated with the company's existing product line, the biomarker assay demonstrated prognostic utility in fibrosis and cancer studies1. NordicEndotrophin™ joins nordicPRO-C6™ and nordicPRO-C3™ (in-house version

First clinical application of accelerator-based boron neutron capture therapy outside of Asia Ongoing clinical trial is enrolling patients with inoperable, locally recurrent head and neck cancer HELSINKI and BOSTON, May 16, 2025 /PRNewswire/ -- Neutron Therapeutics LLC and the Helsinki University Hospital announce that they have treated the first cancer patients in a European hospital with accelerator-based boron neutron capture therapy (BNCT). This milestone marks the culmination of a multi-yea

BioMarin Pharmaceutical will acquire Boston-based Inozyme Pharma for $4.00 per share in an all-cash transaction for a total of about $270 million, adding a late-stage enzyme replacement therapy to its portfolio of treatments for rare genetic disorders. The transaction is expected to close in the third quarter.The deal centres on Inozyme's lead investigational treatment INZ-701, currently in Phase III for ENPP1 deficiency, a rare genetic condition affecting blood vessels, soft tissues and bones t

Shanghai-based ArkBio on Thursday announced promising top-line results from a mid-stage study of AK3280 — a next-generation anti-fibrotic drug to treat idiopathic pulmonary fibrosis (IPF) — demonstrating significant improvements on lung function measures..According to ArkBio, AK3280 is designed to target multiple fibrosis-related pathways, thereby reducing fibroblast proliferation and inhibiting extracellular matrix buildup, without exhibiting gastrointestinal adverse effects (AEs) that often co

Several big pharmas attempting to introduce a rebate model under the 340B programme, rather than offering an upfront discount on medicines, were hit with a setback Friday after a US district judge rejected lawsuits from several drugmakers. Bristol Myers Squibb, Eli Lilly and Johnson & Johnson had each filed suit last year after the US Health Resources and Services Administration (HRSA) rejected proposals from the drugmakers that would change how they deliver reduced-cost drugs to hospitals and c

Safety and early functional results from three patients who received Rocket Pharmaceuticals' heart disease gene therapy were enough to convince the drugmaker to begin planning a pivotal study of RP-A601. But convincing the FDA's new head of the Center for Biologics Evaluation and Research (CBER) — who has criticised the accelerated approval pathway, particularly for gene therapies — may prove a bigger hurdle. Rocket's Thursday presentation at the American Society of Gene and Cell Therapy (ASGCT)