European Medicines Agency (EMA)
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840 articles about European Medicines Agency (EMA)
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
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.
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.
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.
European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
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.
European Medicines Agency (EMA) Grants Orphan Drug Designation (ODD) to GC Biopharma's Treatment for Sanfilippo Syndrome (Type A)
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.
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
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.
Astellas Pharma Inc. contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium.
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.
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
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).
Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa
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.
Anavex Initiates Regulatory Submission of Oral Blarcamesine for Alzheimer’s Disease to European Medicines Agency (EMA)
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.
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
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®.
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
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.
Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Announces CHMP Accelerated Assessment
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.
Annexon, Inc. announced that the European Medicines Agency has granted Priority Medicine designation to ANX007 for the treatment of geographic atrophy secondary to age-related macular degeneration.
Merck Receives Positive EU CHMP Opinion for PREVYMIS® for Prevention of CMV Disease in High-Risk Adult Kidney Transplant Recipients and Extended 200-Day Dosing in Adult HSCT Recipients at Risk for Late CMV Infection and Disease
Merck, known as MSD outside of the United States and Canada, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of PREVYMIS® for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk.
Rezolute Receives Priority Medicines (PRIME) Eligibility from European Medicines Agency for Enhanced Regulatory Support of RZ358 in Congenital Hyperinsulinism
Rezolute, Inc. announced that the European Medicines Agency has granted Priority Medicines eligibility to RZ358 for the treatment of congenital hyperinsulinism.
Bracco Imaging S.p.A. received notification that the CHMP of the EMA has adopted a positive opinion recommending approval of Vueway® solution for injection for magnetic resonance imaging for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging of the CNS and several body organs.
Annexon Announces Clinical and Regulatory Progress for ANX005 Pivotal Program in Guillain-Barré Syndrome (GBS)
Annexon, Inc. announced that the European Medicines Agency granted orphan drug designation to ANX005 for the treatment of Guillain-Barré Syndrome.
CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head & Neck Cancer
CEL-SCI Corporation reported it has filed a request for Scientific Advice regarding Multikine* immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck with the European Medicines Agency’s Scientific Advice Working Group.