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🇪🇺 EuropeLatest pharmaceutical news, drug approvals, and EMA regulatory updates.
Breaking FDA Approves Auvelity for MDD: Axsome Therapeutics Scores Win
The U.S. Food and Drug Administration (FDA) has approved Auvelity, a novel oral antidepressant developed by Axsome Therapeutics, for the treatment of Major Depressive Disorder (MDD) in adults. This approval represents a significant advancement in the mental health landscape.
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Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
Vanda Pharmaceuticals announces commercial availability of NEREUS (tradipitant), the first new prescription motion sickness treatment in over 40 years.
Takeda's TAK-881 Meets Primary Endpoint in Phase 2/3 Trial for Primary Immunodeficiency Disease
Takeda announces positive topline results for TAK-881, showing pharmacokinetic comparability to HYQVIA in pivotal Phase 2/3 trial for PID patients.
Pulse Biosciences Reports 100% Success Rate in Atrial Fibrillation Treatment Trial at Heart Rhythm 2026
Pulse Biosciences achieves 100% procedural success in atrial fibrillation treatment study with 95 evaluable patients at 6 months, presenting data at Heart Rhythm 2026.
SQ Innovation's Lasix ONYU Subcutaneous Heart Failure Trial Results to Be Presented at Heart Failure 2026
SQ Innovation announces SUBCUT HF II trial results for Lasix ONYU, the first at-home subcutaneous furosemide treatment for heart failure edema, May 9th.
Krystal Biotech Reports Strong Q1 2026 Results with VYJUVEK Global Expansion and Two Registrational Studies Pending
Krystal Biotech announces Q1 2026 results highlighting VYJUVEK global expansion and two upcoming registrational study readouts for gene therapy pipeline.
Acurx DNA pol IIIC Inhibitors Show Gut Microbiome Preservation in MRSA Treatment Study at ESCMID Global 2026
Acurx presents promising data showing DNA pol IIIC inhibitors effectively treat MRSA infections while preserving gut microbiome, addressing key antibiotic concern.
BioCryst Secures $70M Upfront in European Licensing Deal for Navenibart Hereditary Angioedema Treatment
BioCryst receives $70M upfront plus milestone payments up to $275M for navenibart licensing agreement with Neopharmed Gentili's Irish affiliate in Europe.
Biosimulation Market to Reach $11.3 Billion by 2031 as Pharmaceutical Companies Accelerate Digital Drug Development
The global biosimulation market will grow 16%+ annually to $11.3 billion by 2031, driven by pharmaceutical companies adopting digital modeling for faster drug development.
GRIN Therapeutics Expands Phase 3 Beeline Study for Radiprodil to Europe for GRIN-NDD Treatment
GRIN Therapeutics initiates Phase 3 Beeline study in Europe for investigational radiprodil targeting GRIN-NDD, expanding global clinical program.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Receives Key Diabetes Drug Approval
FDA approves LANGLARA (insulin glargine-aldy) as interchangeable biosimilar to Lantus for diabetes treatment in adults and pediatric patients.
Vertex CASGEVY Gene Therapy Reaches 60,000+ Eligible Patients Across 10 Countries as Q1 2026 Results Show Global Expansion
Vertex's CASGEVY, the first approved CRISPR gene therapy, now serves 60,000+ eligible sickle cell disease and beta thalassemia patients across 10 countries.
Oncolytics Biotech Pelareorep Shows Durable Responses in RAS-Mutant Colorectal Cancer Trial
Oncolytics Biotech reports sustained clinical benefit with pelareorep immunotherapy in second-line RAS-mutant MSS colorectal cancer patients.
Nuvation Bio's IBTROZI Generates $18.5M Revenue in Q1 2026, Shows Strong First-Line Adoption in ROS1+ NSCLC
Nuvation Bio reports $18.5M Q1 2026 revenue for IBTROZI (taletrectinib) with majority of 200 new patients being TKI-naïve ROS1+ NSCLC cases.
Swiss Biotech Day: Key Takeaways and Industry Trends
Swiss Biotech Day 2024 convened industry leaders to discuss emerging technologies, regulatory frameworks, and strategic partnerships shaping the European biotech landscape. Key themes included precision medicine, digital health integration, and investment trends in a competitive global market.
Purdue Pharma Shutdown: $7.4B Deal Ends OxyContin Maker's Operations
Purdue Pharma, the manufacturer of OxyContin, is ceasing operations following a $7.4 billion settlement agreement. This landmark deal aims to address the company's role in the opioid crisis and provide compensation to victims.
EULAR 2026: Immutep's IMP761 Phase I Data Preview
Immutep will present Phase I clinical trial data for its investigational drug IMP761 at the EULAR 2026 Congress. IMP761, a first-in-class LAG-3 agonist antibody, is being developed for the treatment of autoimmune diseases.
Novelty Nobility Expands AGC Biologics Partnership for Bispecific Antibody Manufacturing
South Korean biotech Novelty Nobility expands manufacturing deal with AGC Biologics to advance bispecific antibody candidate through GMP production in Japan.
Smartee Denti-Technology Advances Mandibular Repositioning Technology at European Aligner Society Congress 2026
Smartee Denti-Technology presents breakthrough mandibular repositioning innovations and European expansion strategy at EAS Congress 2026 in Brussels.
Swiss Biotech Day 2026: AI, Oncology, Microbiome Highlights
Swiss Biotech Day 2026 in Basel highlights AI in drug discovery, precision oncology, and microbiome therapies, featuring presentations from Evotec, Nvidia, and Ferring Pharmaceuticals.