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
846 articles about European Medicines Agency (EMA)
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PTC Announces Submission of Sepiapterin MAA for Treatment of PKU to EMA
3/28/2024
PTC Therapeutics, Inc. announced the submission of the sepiapterin MAA to the European Medicines Agency.
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Positive Feedback From the EMA and FDA on Alzprotect's Phase 2b/3 Development Strategy for PSP
3/13/2024
ALZPROTECT is thrilled to announce that it has received favorable feedback from both the American and European authorities regarding the regulatory path for advancing the clinical development of Ezeprogind/AZP2006 for patients with PSP.
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Madrigal Pharmaceuticals Announces EMA Validation of its Marketing Authorization Application for Resmetirom for the Treatment of NASH/MASH with Liver Fibrosis
3/5/2024
Madrigal Pharmaceuticals, Inc. announced that the Company’s Marketing Authorization Application for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis with liver fibrosis has been validated and is now under evaluation with the European Medicines Agency’s Committee for Medicinal Products for Human Use.
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CymaBay Announces European Medicines Agency Accepts for Review the Marketing Authorization Application for Seladelpar for the Treatment of Primary Biliary Cholangitis
3/4/2024
CymaBay Therapeutics, Inc. announced that the Marketing Authorization Application for seladelpar, for the treatment of primary biliary cholangitis including pruritus in adults without cirrhosis or with compensated cirrhosis who are inadequate responders or intolerant to ursodeoxycholic acid), has been validated and will now be reviewed by the European Medicines Agency.
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BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer
2/26/2024
BeiGene, Ltd. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of tislelizumab as a treatment for non-small cell lung cancer across three indications.
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Biogen’s QALSODY® (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Received Positive Opinion from CHMP
2/23/2024
Biogen Inc. announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a marketing authorization under exceptional circumstances for QALSODY® for the treatment of adults with amyotrophic lateral sclerosis, associated with a mutation in the superoxide dismutase 1 gene.
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AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic SclerosisFirst-in-class, peripheral-acting serotonin receptor antagonist being developed as an anti-fibrotic treatment for systemic sclerosis
2/5/2024
AnaMar, a clinical-stage biotech company developing first-in-class anti-fibrotic 5-HT2B receptor antagonists, announces that the European Medicines Agency and the United States Food and Drug Administration have granted orphan drug designation to its lead clinical candidate, AM1476 for the treatment of systemic sclerosis.
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Nurexone Biologic Initiates European Orphan Drug Designation Process Following U.S. Grant
2/2/2024
NurExone Biologic Inc. is pleased to announce the initiation of the Orphan Drug Designation process with the European Medicines Agency for its groundbreaking ExoPTEN product, currently in development for patients with acute spinal cord injury.
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Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma
2/2/2024
Regeneron Pharmaceuticals, Inc. announced that the European Medicines Agency has accepted for review the Marketing Authorization Application for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma who have progressed after at least three prior therapies.
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European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
1/26/2024
Astellas Pharma Inc. and Pfizer Inc. announced that on Jan. 26, 2024 the European Medicines Agency validated for review a Type II variation application for PADCEV™ with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.
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European Medicines Agency (EMA) Grants Orphan Drug Designation (ODD) to GC Biopharma's Treatment for Sanfilippo Syndrome (Type A)
1/23/2024
GC Biopharma Corp. announced that the European Medicines Agency has granted Orphan Drug Designation to its intracerebroventricular Enzyme Replacement Therapy candidate, GC1130A, designed for Sanfilippo Syndrome type A, developed in collaboration with Novel Pharma.
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AiCuris Received 15 Million Euros Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS(R) for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients
1/9/2024
AiCuris Anti-infective Cures AG announced that it has received milestone payments in the amount of EUR €15 million from its licensing partner MSD ) following EMA approval for the first-in-class antiviral agent PREVYMIS® for the prophylaxis of CMV disease after kidney transplant in Donor CMV-seropositive/Recipient CMV-seronegative patients at high risk.
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EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children
12/17/2023
Astellas Pharma Inc. contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium.
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The European Medicines Agency is seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class.
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AbbVie Announces U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) Updates for Epcoritamab (EPKINLY®/TEPKINLY®) for the Treatment of Relapsed/Refractory Follicular Lymphoma
11/27/2023
AbbVie (NYSE: ABBV) today announced updates from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL).
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Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa
11/27/2023
Krystal Biotech, Inc. today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.
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Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)
11/20/2023
Anavex Life Sciences Corp., a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced that representatives of Anavex met with team members of the European Medicines Agency.
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STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
11/10/2023
Partners STADA and Alvotech announced that the Committee for Medicinal Products for Human Use within the European Medicines Agency has adopted a positive opinion for Uzpruvo, a biosimilar candidate to Stelara®.
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European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
10/30/2023
Bristol Myers Squibb announced that the European Medicines Agency has validated its type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, based on results from the Phase 3 CheckMate -901 trial.
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Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment
10/25/2023
Valneva SE announces the submission of a marketing application with the European Medicines Agency for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553.