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
850 articles about European Medicines Agency (EMA)
-
Genmab Announces AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY®) for the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
7/21/2023
Genmab A/S announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
-
Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301
7/17/2023
Aridis Pharmaceuticals, Inc. announced positive feedback from the European Medicines Agency on the Company’s proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301, which is being developed as an adjunctive therapy in combination with standard of care antibiotics for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients.
-
FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
6/27/2023
Pfizer Inc. announced that the U.S. Food and Drug Administration has accepted the company’s Biologics License Application for fidanacogene elaparvovec for the treatment of adults with hemophilia B. In parallel, the European marketing authorization application for fidanacogene elaparvovec has also been accepted and is under review by the European Medicines Agency.
-
Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency
6/15/2023
Takeda and HUTCHMED Limited announced that the European Medicines Agency has validated and accepted for regulatory review the marketing authorization application for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer.
-
Enzolytics Offers Update on Virogentics and Sale Transaction, Clinical Trials Progress on European Medicine Agency (EMA) Permitting and Arican ITV-1 Project
6/5/2023
Enzolytics, Inc. provided updates regarding the sale of Virogentics, Inc. and Biogenysis, Inc. to Sagaliam Acquisition Corp and details of the recently released comprehensive study prepared by the Bulgarian Academy of Science for use by Korporativ Klinik Drug Research and Development as part of the continued development of the program to meet EMA requirements for clinical trials.
-
Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable NSCLC at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%
5/26/2023
Bristol Myers Squibb announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
-
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
5/19/2023
Sobi announced that the European Medicines Agency has accepted and validated a marketing authorisation application for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups.
-
Biophytis has Filed with the EMA for Authorization to Initiate SARA-31 Phase 3 Study in Sarcopenia
5/15/2023
Biophytis SA announced that it has submitted the application for Clinical Trial Authorization to initiate SARA-31, the first phase 3 study in sarcopenia, on the European portal of the EMA.
-
Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay
5/11/2023
We are pleased to announce that Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI and the EMA as a Class C CDx assay, meeting the stringent new IVDR 2017/746) requirements.
-
Biophytis has Requested a Pre-Submission Meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the Treatment of COVID-19
5/9/2023
Biophytis SA announced that it has filed for a pre-submission meeting request with the European Medicine Agency to discuss filing for conditional Marketing Authorisation in Europe for Sarconeos in the treatment of severe form of COVID-19.
-
Veristat Congratulates HIPRA for EMA Approval of Its BIMERVAX® COVID-19 Vaccine
4/25/2023
Veristat congratulated HIPRA for marketing authorization by the European Medicines Agency and European Commission of BIMERVAX®, a bivalent adjuvanted vaccine based on the Beta and Alpha variants of SARS-CoV-2 and indicated as a booster dose for people over 16 years of age.
-
AB Science announces that it has submitted its response to the day 120 questions in the EMA regulatory review of masitinib in amyotrophic lateral sclerosis and clarifies the new timeline for responding to Health Canada
4/4/2023
AB Science S.A. provides an update on the schedule for the evaluation by the Committee for Medicinal Products for Human Use of the European Medicines Agency and by Health Canada of its applications for conditional approval of masitinib in the treatment of amyotrophic lateral sclerosis.
-
Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
3/16/2023
Biogen Inc. announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency, and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® because of TECFIDERA’s regulatory data and marketing protection.
-
Genethon Given PRIME Status by EMA for Gene Therapy To Treat Crigler-Najjar Syndrome, a Rare Liver Disease
3/7/2023
Genethon, a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association, announced that the European Medicines Agency has granted PRIME status to the gene therapy, GNT-0003, currently in clinical trials for Crigler-Najjar syndrome, a rare liver disease.
-
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderate to Severe Crohn's Disease
2/27/2023
AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of upadacitinib for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4
-
Libtayo® (cemiplimab) in Combination with Chemotherapy Receives Positive CHMP Opinion for the Treatment of Advanced PD-L1 Positive Non-small Cell Lung Cancer (NSCLC)
2/24/2023
Regeneron Pharmaceuticals, Inc. announced the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo® in combination with platinum-based chemotherapy.
-
Pharming provides update on EMA regulatory review of leniolisib for APDS in Europe
2/16/2023
Pharming Group N.V. announces that the European Medicines Agency's Committee for Human Medicinal Products has decided to shift its assessment of the Marketing Authorisation Application for leniolisib to a standard review timetable.
-
EMA Confirms Acceptance of Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)
2/9/2023
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and global pharmaceutical company STADA Arzneimittel announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara®.
-
Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis
12/22/2022
Everest Medicines announced that its licensing partner, Pfizer Inc. has received acceptance from the U.S. Food and Drug Administration for review a New Drug Application for etrasimod for individuals living with moderately-to-severely active ulcerative colitis.
-
Hansa Biopharma announces positive reimbursement decision in Italy for Idefirix® (imlifidase) as desensitization treatment for highly sensitized patients in kidney transplantation
12/8/2022
Hansa Biopharma announces that the Italian Medicine Agency has granted full access and reimbursement for the use of Idefirix®, the company's first-in-class treatment, for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor.