European Medicines Agency– tag –
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BioNTech Announces gotistobart Phase III Achieves Median OS of 18.5 Months in Squamous NSCLC at WCLC 2026
european biotechnology Germany Overview At the World Conference on Lung Cancer (WCLC) 2026 in Seoul, BioNTech presented pivotal data from the Phase III PRESERVE-003 trial for gotistobart (BNT316/ONC-392), a pH-sensitive anti-CTLA-4 antib... -
Ribo Life Science’s siRNA Therapeutic Vortosiran Receives EMA Approval for Stroke Prevention Trial in Atrial Fibrillation Patients
Insight, China's Pharmaceutical Industry China Overview Ribo Life Science's siRNA therapeutic, vortosiran (BD4059), has received European Medicines Agency (EMA) approval for a clinical trial aimed at stroke prevention in atrial fibrillat... -
Daiichi Sankyo/AstraZeneca’s Datroway Receives US FDA Approval for First-Line Metastatic TNBC, EMA CHMP Gives Positive Opinion
Chemistry Today USA Overview Datroway (datopotamab deruxtecan), the TROP2-directed DXd ADC co-developed by Daiichi Sankyo and AstraZeneca, has received US FDA approval as a first-line treatment for unresectable or metastatic triple-negat... -
CAR T-Cell Therapy Clinical Trial Landscape for Non-Hodgkin Lymphoma Expands with Over 70 Companies Developing Next-Gen Treatments
GlobeNewswire Global Overview A report by DelveInsight, released via GlobeNewswire, offers a detailed analysis of the CAR T-cell therapy clinical trial landscape for Non-Hodgkin Lymphoma (NHL). The report highlights over 70 companies adv... -
CDMO Curia Massively Expands Sterile Fill-Finish Capacity in UK, US for Biologics and ADCs
Packaging Digest UK, USA Overview CDMO Curia has significantly expanded its sterile fill-finish manufacturing facilities in Glasgow, UK, and Albuquerque, US, to meet surging demand for biologics and highly potent antibody-drug conjugates... -
REPROCELL Accelerates Clinical Production with FDA/EMA/PMDA-Compliant iPSC Manufacturing Platform
REPROCELL Japan Overview REPROCELL has unveiled a robust iPSC manufacturing scale-up strategy aimed at accelerating clinical development and commercialization of iPSC-based therapeutics. Their StemRNA™ Clinical iPSC Platform offers clini... -
FDA Expands Regulatory Flexibility for Cell and Gene Therapies, Streamlining CMC Requirements to Accelerate Early Clinical Development
Medicinova, Inc. (Facebook) USA Overview The US FDA has announced an expansion of regulatory flexibility for Cell and Gene Therapy (CGT) products, particularly adapting Chemistry, Manufacturing, and Controls (CMC) requirements across the... -
EMA’s CHMP Endorses Marketing Authorization Expansion for Rhythm Pharmaceuticals’ IMCIVREE (setmelanotide) for Childhood Obesity in Rare Genetic Disorders (Ages 2+)
Bio-Research.AI Europe Overview Rhythm Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization expansion for IMCIVREE (setmelanoti... -
Bridging the Data Integrity Gap in Pharmaceutical Quality Control: Ensuring Reliability for Advanced Medicinal Products
European Pharmaceutical Review EU Overview The critical importance of closing the data integrity gap in pharmaceutical quality control has been re-emphasized. For advanced medicinal products like cell and gene therapies, stringent reliab... -
Cellistic Expands iPSC Therapy Manufacturing with New GMP Platforms for Immuno-Oncology and Regenerative Medicine
Cellistic Press Release (via PharmaTimes) Belgium Overview Cellistic has introduced three new GMP manufacturing platforms—Echo-T, Echo-Cardio, and Echo-Endothelial—significantly expanding its capabilities for iPSC-derived cell therapies....
