European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London
E14 4HB
United Kingdom
Tel: 44-0-20-7523-7600
Website: http://www.ema.europa.eu/ema/
Email: info@ema.europa.eu
751 articles with European Medicines Agency (EMA)
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AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.
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Instem Awarded EMA Research Grant
5/10/2022
Instem announced that it has been awarded a European Medicines Agency grant as part of an EMA-funded research project to better understand the mutagenicity of N-nitrosamines.
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Moderna Files to Expand Conditional Marketing Authorization for Its COVID-19 Vaccine to Include Children Six Months to Under Six Years in The European Union
4/29/2022
Moderna, Inc. announced that it has submitted for a variation to the conditional marketing authorization with the European Medicines Agency for the evaluation of a 25 µg two-dose series of Spikevax, the Company's vaccine against COVID-19, in children six months to under six years of age.
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BeiGene, Novartis Drug Tislelizumab Demonstrates Strong Survival Benefit in Esophageal Cancer
4/27/2022
BeiGene's candidate drug tislelizumab for cancer succeeded in meeting the primary endpoint of overall survival in a global Phase III trial. Learn more about it here. -
Biogen has withdrawn its Marketing Authorization Application (MAA) for European approval of Aduhelm after regulators hinted data was not strong enough to support potential approval.
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BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC
4/6/2022
BeiGene, Ltd. announced that marketing authorization applications for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency for patients with advanced or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy and for patients with non-small cell lung cancers.
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With the accelerated approval from the U.S. Food and Drug Administration, Vijoice becomes the first treatment approved in the United States for PROS
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Gadopiclenol Marketing Authorization dossier submissions accepted for review by EMA and FDA
3/29/2022
Guerbet has recently submitted a New Drug Application to the U.S. Food and Drug Administration and a Centralized Application for Marketing Authorization to the European Medicine Agency for Gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent.
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Sanofi and IGM Biosciences inked a collaboration deal for oncology, immunology and inflammation that could surpass $6 billion.
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European Medicines Agency Commences Review of Novel Gene Therapy Candidate Etranacogene Dezaparvovec for People with Hemophilia B
3/28/2022
Global biotherapeutics leader CSL Behring announced that the European Medicines Agency has accepted the Marketing Authorization Application for etranacogene dezaparvovec under its accelerated assessment procedure.
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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors in Five Different Types of Cancer
3/25/2022
Merck announced the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of the following microsatellite instability-high or mismatch repair deficient tumors in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy;
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The FDA approved Pluvicto (targeted radioligand therapy) for use in adults with PSMA-positive mCRPC that has already metastasized to other body parts.
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Calliditas provides a regulatory update on EMA process for Nefecon
3/22/2022
Calliditas Therapeutics AB announced that the opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency can be expected in Q2, 2022.
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Bristol Myers Squibb and Nektar Therapeutics said their joint Phase III PIVOT IO-001 study did not meet two endpoints: progression-free survival and objective response rate.
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CELTIC-19 Granted Advanced Therapy Medicinal Product Classification by European Medicines Agency
3/8/2022
Ixaka Ltd, an integrated cell and gene therapy company, announces that Advanced Therapy Medicinal Product classification has been granted by the European Medicines Agency for its Chemically Encapsulated Lentiviral vector for Targeted In Vivo CAR T-cell therapy targeted nanoparticle product.
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Hansa Biopharma announces positive early access decision by French Haute Autorité de Santé to use Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients
2/26/2022
Hansa Biopharma AB announces that its first-in-class treatment Idefirix® has been granted early access post marketing authorization in France by French HAS for use in the desensitization of highly sensitized adult patients prior to kidney transplant, in accordance with the patient population specified in the Marketing Authorization received from the European Medicines Agency.
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Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for First-Line Treatment of Patients with Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
2/25/2022
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo plus Yervoy for the first-line treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥ 1%.
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Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma with Tumor Cell PD-L1 Expression ≥1%
2/25/2022
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection.
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Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
2/25/2022
Immunocore Holdings plc announces that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the approval of KIMMTRAK® for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
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New two-year data from Phase III studies of Susvimo and Vabysmo reinforce the two drugs' potential to improve the quality of life of patients diagnosed with DME and nAMD.