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Sanofi's Nuvaxovid COVID-19 Vaccine Shows Superior Tolerability Over mNEXSPIKE in Phase 4 Study
Sanofi's protein-based Nuvaxovid COVID-19 vaccine demonstrated better tolerability than mNEXSPIKE in first head-to-head phase 4 study presented at ESCMID.
Brand Institute Receives First EMA Approval for AI-Developed Pharmaceutical Brand Name Using Brandi Platform
Brand Institute achieves regulatory milestone as EMA approves first pharmaceutical brand name developed using AI-powered Brandi platform technology.
EMA Drug Patent Cliff 2026: Major European Pharmaceutical Exclusivities Set to Expire
Multiple high-cost EMA-approved drugs lose exclusivity in 2026, enabling generic competition and expanded patient access across Europe's healthcare systems.
EMA CHMP Recommends 6 New Medicines for Approval Including Treatments for Menopause, Liver Disease, and Rare Disorders
European Medicines Agency's CHMP recommends 6 new medicines for marketing authorization, covering menopausal symptoms, liver disease, and rare genetic disorders.
EMA Recommends Adstiladrin Gene Therapy for Bladder Cancer Treatment in March 2026
EMA's CHMP recommends conditional approval for Adstiladrin gene therapy to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
EMA Approves Hanmi Pharmaceutical's HMPL-523 Herbal Medicine for Alzheimer's Disease Treatment
European Medicines Agency grants marketing authorization for HMPL-523, marking first herbal medicine approval for mild to moderate Alzheimer's disease treatment.
Gene Therapy Market to Reach $43.8 Billion by 2034 as CRISPR and AAV Technologies Drive 12.27% Annual Growth
Gene therapy market projected to grow 12.27% annually through 2034, driven by CRISPR and AAV advances, with North America leading at 56% market share.
Healthcare Cold Chain Logistics Market to Surge Through 2034 as Biopharmaceutical Demand Drives Asia-Pacific Growth
Healthcare cold chain logistics market projected for significant growth 2026-2034, driven by rising biopharmaceutical demand and Asia-Pacific expansion.
AIM ImmunoTech Advances Ampligen to Phase 3 Pancreatic Cancer Trial with Orphan Drug Status
AIM ImmunoTech plans Phase 3 trial for Ampligen in pancreatic cancer, backed by positive Phase 2 data and orphan drug designations in US and Europe.
AB Science Secures €25 Million Clinical Trial Insurance for Masitinib ALS Phase III Study
AB Science obtains €25M clinical trial insurance for masitinib ALS Phase III study while implementing temporary European trial halt amid regulatory review.
MeiraGTx Acquires Botaretigene Sparoparvovec Gene Therapy from Johnson & Johnson for X-linked Retinitis Pigmentosa Treatment
MeiraGTx acquired botaretigene sparoparvovec from J&J to treat X-linked retinitis pigmentosa, planning immediate global regulatory filings for approval.
Beamion's Zongertinib Receives FDA Accelerated Approval for HER2-Mutant NSCLC as LUNG-1 Study Results Published in NEJM
Beamion's zongertinib gains FDA accelerated approval for HER2-mutant NSCLC treatment following breakthrough therapy designation and NEJM publication.
TRI-611 Receives FDA Fast Track Designation for ALK-Positive Non-Small Cell Lung Cancer as Competition Intensifies
TRI-611 molecular glue degrader gains FDA fast track status for ALK-positive NSCLC while Eisai's taletrectinib advances in Europe for ROS1+ lung cancer treatment.
Traws Pharma Advances Tivoxavir Marboxil to Human Influenza Challenge Trial, Reports Positive Ratutrelvir COVID Data
Traws Pharma advances tivoxavir marboxil for once-monthly flu prevention and reports differentiated COVID treatment data for ratutrelvir versus Paxlovid.
TME Pharma NOX-A12 Triple Therapy Shows Promise in Brain Cancer GLORIA Trial Published in Nature Communications
TME Pharma announces Nature Communications publication of NOX-A12 triple therapy Phase 1/2 GLORIA trial results for brain cancer treatment.
New Additional Risk Minimization Measures (aRMMs) Training Course Launches to Enhance Pharmaceutical Patient Safety Protocols
PharSafer Associates launches comprehensive aRMMs training course focusing on regulatory frameworks and patient safety evaluation strategies for pharma professionals.
Healthcare Logistics Market to Surge $159.91 Billion by 2030, Driven by Biopharmaceutical Growth and Cold Chain Expansion
Global healthcare logistics market projected to grow $159.91 billion from 2025-2030 with 14.4% CAGR, driven by biopharmaceutical expansion and cold chain demands.
Medical Device Software Compliance Training Launches for EU MDR, IVDR and FDA Regulations in June 2026
New online training course addresses critical medical device software compliance requirements under EU MDR, EU IVDR, and FDA regulations starting June 22-26, 2026.
ONWARD Medical Raises €40 Million in Capital Increase Led by EQT Life Sciences for Spinal Cord Stimulation Technology
ONWARD Medical secures €40M funding with €25M from EQT Life Sciences to advance spinal cord stimulation therapies for paralysis and movement disorders.
SAHPRA and African Medicines Agency Launch Continental Pharmaceutical Regulatory Harmonization Course for May 2026
SAHPRA partners with African Medicines Agency for comprehensive regulatory affairs course covering continental harmonization and product registration.