The 2026 HIMSS European Health Conference & Exhibition will bring together leading voices in digital health from 19–21 May, 2026, in Copenhagen, Denmark. As one of the premier gatherings for healthcare innovation, the event will spotlight world-class speakers and cutting-edge discussions addressing the most pressing challenges and opportunities across the healthcare ecosystem.

Cellenkos®, Inc., a clinical stage biotechnology company, pioneering allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD). Steroid-refractory GVHD represents a critical unmet need in post-transplant care. While allo

Dr. Reddy’s Laboratories Ltd. a global pharmaceutical company, today announced that it has received a Notice of Compliance (NOC) from Health Canada for its generic Semaglutide Injection. Dr. Reddy’s becomes the first company to receive the market authorization for generic Semaglutide Injection* in Canada, ahead of Health Canada’s review target date. The market authorization covers the 2 mg / pen (1.34 mg / mL) and 4 mg / pen (1.34 mg / mL). With launch preparations underway,

Insilico Medicine a clinical-stage, generative AI–driven drug discovery company, today announced that the inhalation solution of Rentosertib (ISM001-055), the company's first-in-class drug candidate with AI-identified novel target and AI-developed molecule structure, received IND clearance from CDE. Notably, Rentosertib inhalation solution is the 13th program from Insilico's AI-driven pipeline to receive IND clearance, further demonstrating how Pharma.AI could reproducibly drive

Pfizer Inc. today announced that it has entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the U.S. District Court for the District of Delaware for infringement of patents relating to VYNDAMAX® (tafamidis), a treatment for cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM). These settlements extend the effective U.S. patent expiry date for VYNDAMAX to June 1, 2031, subject to the outco

Terns Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to TERN-701 for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in the chronic phase. The designation applies to patients without the T315I mutation who have previously been treated with two or more tyrosine kinase inhibitors (TKIs). TERN-701 is an oral, allosteric BCR::ABL1 inhibitor being develop

Mabwell an innovation-driven biopharmaceutical company with a fully integrated industry chain, announces the initiation of a Phase III clinical study of its proprietary Nectin-4-targeting ADC for the treatment of triple-negative breast cancer (TNBC). 9MW2821 is the world's first Nectin-4 ADC to enter Phase III clinical study for TNBC. This marks the fourth pivotal trial initiated for 9MW2821. This is a randomized, open-label, controlled, multicenter Phase III clinical study desi

Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3 disease), Krabbe disease (globoid cell leukodystrophy), and Sandhoff disease (GM2 gangliosidosis Type II). Following the March 2026 grant of FTD to PLX-

Eli Lilly and Company (NYSE: LLY) and Kelonia Therapeutics, Inc. ("Kelonia"), a clinical-stage biotechnology company pioneering in vivo gene delivery, today announced a definitive agreement for Lilly to acquire Kelonia. Kelonia has developed a proprietary in vivo gene placement system (iGPS® ) that uses specially engineered lentiviral-based particles designed to efficiently and selectively enter T-cells inside the body, allowing the patient's own body to generate c

Adcendo ApS ("Adcendo"), a biotech company focused on the development of first- and best-in-class antibody-drug conjugates (ADCs) for the treatment of cancers with high unmet medical need, today announced multiple clinical and regulatory updates for the Company's pipeline of first- and best-in-class ADCs. ADCE-T02 has advanced into cohort expansion portion of Tiffany-01 study. ADCE-T02 is a potential best-in-class Topo-I inhibitor-based ADC targeting tissue factor (TF)