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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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Biotheryx BTX-9341 Phase 1A Results to Be Presented at ESMO Breast Cancer Congress 2026
Biotheryx announces Phase 1A dose escalation study results for BTX-9341, a CDK4/6 degrader for HR+/HER2- breast cancer treatment at ESMO 2026.
RAPS Euro Convergence 2026: Regulatory News - Day 1 Roundup
RAPS Euro Convergence 2026 commenced on May 5, 2026, in Lisbon, Portugal, bringing together European regulatory affairs professionals to discuss EMA guidelines, compliance strategies, and market access pathways. No breaking pharmaceutical announcements were reported on Day 1.
Heart Failure 2026: Vutrisiran Data & European Pharma News
Alnylam Pharmaceuticals to present new data analyses for vutrisiran in ATTR-CM at Heart Failure 2026. The Hello Tomorrow Global Summit positions itself as Europe's leading deeptech crossroads.
CVRx Enrolls First Patient in BENEFIT-HF Heart Failure Trial Testing Barostim Device
CVRx begins landmark BENEFIT-HF clinical trial for Barostim neuromodulation device in expanded heart failure patient population at Avera Heart Hospital.
Agenus Announces Q1 2026 Financial Report Date for Botensilimab and Balstilimab Cancer Programs
Agenus will provide Q1 2026 financial results and corporate update on botensilimab and balstilimab cancer immunotherapy programs with regulatory timeline guidance.
Oncolytics Biotech Reports Durable Responses with Pelareorep in RAS-Mutant Colorectal Cancer Trial
Oncolytics Biotech announces sustained clinical benefit with pelareorep immunotherapy in patients with RAS-mutant, microsatellite-stable colorectal cancer.
CRISPR Therapeutics Reports Q1 2026 Results as CASGEVY Gene Therapy Gains Global Regulatory Approval
CRISPR Therapeutics reports Q1 2026 financial results highlighting CASGEVY's approval in 10+ countries for sickle cell disease and beta thalassemia treatment.
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.