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News about "EMA"
AbbVie Submits FDA Application for SKYRIZI Subcutaneous Induction in Crohn's Disease
AbbVie Inc. submits an application to the US Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa) subcutaneous induction in Crohn’s disease, supported by Phase 3 AFFIRM data, offering a potential new treatment option.
EMA | 29/04/2026 | By News Bureau
Soligenix Reports Phase 3 FLASH2 Interim Results for HyBryte in Cutaneous T-Cell Lymphoma
Soligenix reports Phase 3 FLASH2 interim results for HyBryte in Cutaneous T-Cell Lymphoma, with the study recommended for early termination due to futility.
EMA | 29/04/2026 | By News Bureau
Eisai Submits EMA Application for Once-Monthly Maintenance Dosing of Alzheimer's Drug Lecanemab
BioArctic partner Eisai has filed a Marketing Authorisation Variation with the EMA seeking approval for a once-every-four-weeks IV maintenance dosing regimen for lecanemab in early Alzheimer’s disease.
EMA | 27/01/2026 | By News Bureau | 110
Sanofi's Efdoralprin Alfa Gains EU Orphan Designation for AATD Emphysema
Sanofi’s investigational restorative recombinant therapy efdoralprin alfa has received EU orphan drug designation for alpha-1 antitrypsin deficiency–related emphysema, following positive phase II head-to-head results demonstrating success across all primary and key secondary endpoints versus the current plasma-derived standard of care.
EMA | 20/12/2025 | By News Bureau | 113
EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats
Under the new system, medicine developers can receive joint scientific advice from EMA and national clinical and ethics experts. This coordinated approach aligns trial and regulatory requirements early, helping accelerate trial approvals and access to critical medicines.
EMA | 18/11/2025 | By Dineshwori | 315
EMA Recommends EU Approval for Waskyra to Treat Wiskott-Aldrich Syndrome
The EMA has recommended EU marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for patients aged six months and older with Wiskott-Aldrich Syndrome (WAS). The treatment uses a patient’s own modified stem cells to restore functional WAS protein.
EMA | 17/11/2025 | By Dineshwori | 249
Aurobindo Pharma Ltd's subsidiary to withdraw application for EU Marketing Authorization of two biosimilars
EMA | 26/06/2023 | By Sudeep Soparkar | 1065
WuXi Biologics' drug substance and drug product facilities bags US FDA, EMA approval
These approvals add to the previous 25 certifications from more than 10 global regulatory administrations
EMA | 20/09/2022 | By Sudeep Soparkar | 900
EMA reviews gene therapy for Haemophilia B
EMA (European Medicines Agency) has started reviewing the CSL Behring's MAA for gene therapy etranacogene dezaparvovec (EtranaDez), for the patients getting treatment for Haemophila B.
EMA | 28/04/2022 | By Sudeep Soparkar | 908
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