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Stoke Therapeutics Zorevunersen Shows Promise for Dravet Syndrome Treatment Ahead of Q1 2026 Results
Stoke Therapeutics prepares Q1 2026 earnings call featuring Zorevunersen, an investigational antisense therapy targeting Dravet syndrome's underlying cause.
uniQure AMT-130 Gene Therapy Advances Toward UK Approval for Huntington's Disease Treatment
uniQure completes successful UK MHRA pre-submission meeting for AMT-130 Huntington's disease gene therapy, targeting Q3 2026 marketing authorization application.
Northwest Biotherapeutics Appoints Dr. Annalisa Jenkins as Strategic Adviser for DCVax Cancer Vaccine Development
Northwest Biotherapeutics names Dr. Annalisa Jenkins as Strategic Adviser to advance DCVax dendritic cell cancer vaccine platform with 25+ years biopharma experience.
Cerus Corporation INTERCEPT Blood System Advances Through European Regulatory Review and Phase 3 Trials
Cerus Corporation's INTERCEPT Blood System progresses through European regulatory review while Phase 3 RedeS trial readout and new INT200 device submission planned.
Bio-Rad Q1 2026 Results Show IVDR Compliance Costs Impact European Diagnostics Operations
Bio-Rad reports Q1 2026 financial results highlighting increased costs from EU IVDR compliance and product portfolio rationalization in diagnostics market.
FDA Advisory Committee Recommends AstraZeneca's TRUQAP for PTEN-Deficient Metastatic Prostate Cancer
FDA's Oncologic Drugs Advisory Committee recognizes favorable benefit-risk profile for TRUQAP (capivasertib) in PTEN-deficient metastatic prostate cancer treatment.
Alkeus Pharmaceuticals Presents Gildeuretinol Data for Stargardt Disease at ARVO 2026
Alkeus Pharmaceuticals announces clinical data presentation for investigational oral gildeuretinol treating Stargardt disease at ARVO 2026 meeting.
SetPoint Medical Begins Multiple Sclerosis Trial for Setpoint System Neuroimmune Therapy
SetPoint Medical enrolls first patients in pilot study testing Setpoint System for relapsing-remitting multiple sclerosis treatment with FDA approval.
Emergent BioSolutions Reports Q1 2026 Financial Results: Biodefense Company Updates Revenue Performance
Emergent BioSolutions releases first quarter 2026 financial results, providing insights into the biodefense and pharmaceutical company's performance.
Telix Pharmaceuticals' TLX101-Px (Pixlumi) Brain Cancer Imaging Drug Accepted for European Review
Telix Pharmaceuticals' TLX101-Px (Pixlumi) glioma imaging drug enters 210-day European regulatory review after MAA acceptance, targeting brain cancer diagnosis.
EU Biopharma Clinical Trials: AI & Gene Therapy Surge
EU biopharma clinical trials are undergoing rapid transformation in 2026, driven by AI integration, global trial expansion, and breakthrough advances in cell and gene therapies. These shifts are compressing development timelines and lowering costs, though regulatory pressures and Chinese competition present significant headwinds.
HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder
HUTCHMED announces NDA acceptance with priority review status for sovleplenib to treat warm antibody autoimmune hemolytic anemia in China.
FDA Real-World Evidence Framework Shifts $10B Toward Validated Medtech Platforms Like VentriPoint
FDA's new real-world evidence requirements for medical devices create $10B market shift favoring established platforms with proven performance data.
BioPharma Clinical Trials EU: Daily Insights
The BioPharma Clinical Trials EU conference highlights emerging innovations in clinical trial design, including decentralized models, adaptive pathways, and real-world evidence integration. Recent EMA regulatory updates are reshaping how pharmaceutical sponsors approach drug development timelines and patient engagement across Europe.
European Commission Approves POHERDY, First Pertuzumab Biosimilar in Europe by Henlius and Organon
EC grants marketing authorization for POHERDY (pertuzumab), the first approved biosimilar to PERJETA in Europe, developed by Henlius Biotech and Organon.
PureTech Reports Positive LYT-200 Clinical Results for Myeloid Malignancies in 2025 Annual Results
PureTech announces positive clinical results for LYT-200 in myeloid malignancies, alongside Phase 3-ready deupirfenidone and advancing neuropsychiatric pipeline.
EnteroBiotix Raises £19M to Launch Phase 2b Microbiome Trial for Irritable Bowel Syndrome Treatment
EnteroBiotix secures £19M funding to initiate the largest Phase 2b microbiome trial for IBS treatment, with patient dosing starting Q2 2026.
Ray Therapeutics RTx-015 Receives EMA PRIME Designation for Retinitis Pigmentosa Treatment
Ray Therapeutics' RTx-015 gene therapy receives EMA PRIME designation for retinitis pigmentosa, accelerating regulatory pathway for vision restoration treatment.
X4 Pharmaceuticals Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment in EU
X4 Pharmaceuticals announces European Commission approval for XOLREMDI (mavorixafor), the first authorized treatment for WHIM syndrome patients in the EU.
Norgine Receives European Approval for XOLREMDI (Mavorixafor), First WHIM Syndrome Treatment in EU
Norgine's XOLREMDI becomes the first authorized treatment for WHIM syndrome in Europe, marking a breakthrough for ultra-rare immunodeficiency patients.