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🇪🇺 EuropeLatest pharmaceutical news, drug approvals, and EMA regulatory updates
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Norgine Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment
Norgine's XOLREMDI becomes first authorized treatment for WHIM syndrome in Europe, marking breakthrough for ultra-rare immunodeficiency patients.
EMA Establishes Expert Panel to Strengthen COVID-19 mRNA Vaccine Trust Including Spikevax and Comirnaty
European Medicines Agency forms international expert panel to enhance public confidence in COVID-19 mRNA vaccines including Spikevax and Comirnaty.
Henlius and Organon's POHERDY Becomes First Pertuzumab Biosimilar Approved in Europe
European Commission approves POHERDY as first pertuzumab biosimilar in Europe, offering cost-effective alternative to PERJETA for breast cancer treatment.
EU BioPharma Clinical Trials: Daily Insights & Key Takeaways
The EU biopharma clinical trials landscape continues to evolve with emphasis on patient-centric methodologies, regulatory harmonization, and innovative trial designs. Key developments include implementation of the Clinical Trials Regulation, adoption of decentralized trial models, and integration of real-world evidence in drug development.
EU BioPharma Clinical Trials: Daily Insights
Explore the evolving landscape of EU biopharmaceutical clinical trials, including regulatory frameworks, innovative trial designs, and collaboration opportunities shaping drug development across Europe.
VivoSim Labs Launches AI Tool to Predict Drug-Induced Diarrhea Without Animal Testing
VivoSim Labs unveils AI prediction platform using human intestinal models to forecast gastrointestinal toxicity, eliminating need for animal testing.
Boehringer Ingelheim's Survodutide Achieves 16.6% Weight Loss in Phase 2 Obesity Trial, Outperforming Current Market Leaders
Survodutide delivered 39.2 lb average weight loss in 76-week trial, potentially superior to Wegovy and Zepbound in competitive obesity market.
Idorsia Reports 74% QUVIVIQ Sales Growth in Q1 2026, Expands European Market Reach
Idorsia's insomnia drug QUVIVIQ achieves 74% year-over-year sales growth in Q1 2026, with European expansion and pediatric data driving future growth.
Small Molecule API Market Projected to Reach $202.53 Billion by 2036 as Generic Drug Demand Surges
Small molecule API market set to hit $202.53 billion by 2036, driven by generic drug demand and oncology pipeline expansion across global markets.
Silexion Therapeutics Submits Phase 2/3 Trial Application for SIL204 KRAS-Targeted Pancreatic Cancer Treatment
Silexion Therapeutics successfully submits Phase 2/3 clinical trial application to Germany's BfArM for SIL204, targeting KRAS-driven pancreatic cancer.
Novo Nordisk Presents New Wegovy Data for Women with Obesity at European Congress on Obesity 2026
Novo Nordisk unveils new clinical data on Wegovy for women with obesity and next-generation weight loss treatments at European Congress on Obesity in Istanbul.
Solid Biosciences Receives European Orphan Drug Designation for SGT-003 Duchenne Muscular Dystrophy Treatment
Solid Biosciences secures European Commission orphan drug designation for SGT-003, advancing gene therapy development for Duchenne muscular dystrophy patients.
Cytokinetics MYQORZO (Aficamten) Takes Center Stage at European Society of Cardiology Heart Failure 2026 Congress
Cytokinetics presents nine studies on MYQORZO (aficamten) at ESC Heart Failure 2026, including late-breaking science on the newly approved oHCM treatment.
Artiva Biotherapeutics' AlloNK Receives FDA Fast Track Designation for Refractory Rheumatoid Arthritis Treatment
FDA grants Fast Track Designation to Artiva's AlloNK (AB-101) for refractory rheumatoid arthritis, accelerating development of innovative NK cell therapy.
SQ Innovation's Lasix ONYU Receives CE Marking Approval, Advances Toward European Market Authorization
SQ Innovation announces CE marking for Lasix ONYU medical device under EU MDR, plus EMA centralized procedure eligibility for European market expansion.
BioPharma Clinical Trials: Gene Therapy, Obesity, and Oncology Updates
Updates on gene therapy, oncology, and obesity treatments were presented this week, including Benitec Biopharma's BB-301 for OPMD and Boehringer Ingelheim's survodutide for obesity.
Elanco's Negasunt and Tanidil Receive FDA Emergency Authorization for New World Screwworm Treatment in Livestock
FDA grants emergency use authorization for Elanco's Negasunt Powder and Tanidil to combat New World screwworm in livestock, preparing U.S. veterinarians.
Opella's Essentiale Shows 2.5x Greater Liver Fat Reduction in Breakthrough EXCEL Trial for Fatty Liver Disease
Opella's Essentiale essential phospholipids demonstrated 2.5 times greater liver fat reduction vs diet/exercise alone in MASLD patients in EXCEL trial.
Advanced Bifurcation Systems Acquires Svelte Medical Systems in Major Coronary Stent Deal
Advanced Bifurcation Systems Inc. acquires Svelte Medical Systems, expanding its coronary angioplasty portfolio with drug-eluting stents and regulatory approvals.
Zentiva Appeals EU Court Decision on Urban Wastewater Directive Affecting Generic Medicine Access
Zentiva and generic drugmakers challenge EU Urban Wastewater Directive at CJEU, citing concerns over patient access and medicine affordability in Europe.