European Commission (EC)
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253 articles with European Commission (EC)
bluebird bio Receives EC Approval for SKYSONA™ (elivaldogene autotemcel, Lenti-D™) Gene Therapy for Patients Less Than 18 Years of Age With Early Cerebral Adrenoleukodystrophy (CALD) Without Matched Sibling Donor
bluebird bio, Inc. announced that the European Commission has granted marketing authorization of SKYSONA™, a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age with an ABCD1 genetic mutation, and for whom a human leukocyte antigen -matched sibling hematopoietic stem cell donor is not available.
Myovant Sciences Announces European Commission Approval for RYEQO® for the Treatment of Women With Uterine Fibroids
Myovant Sciences, a healthcare company focused on redefining care for women and for men, announced the European Commission has approved the marketing authorization application for RYEQO® for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use.
The expanded approval was made based on positive data from a second interim analysis of the Phase II KEYNOTE-629 trial.
Valneva Continues Ongoing Discussions with the European Commission for Inactivated COVID-19 Vaccine Candidate
Following a media article published yesterday, ValnevaSE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, indicated it continues ongoing discussions with the European Commission regarding VLA2001, Valneva’s inactivated COVID-19 vaccine candidate.
European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma
Merck announced that the EC has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 -negative gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the Treatment of Mismatch Repair Deficient or Microsatellite Instability–High Metastatic Colorectal Cancer After Prior Chemotherapy
Bristol Myers Squibb announced that the European Commission has approved Opdivo plus Yervoy for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Chugai Pharmaceutical Co., Ltd. announced that Roche has been granted Marketing Authorization from the European Commission for the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng®, created by Chugai, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody seropositive neuromyelitis optica spectrum disorder, as a monotherapy or in combination with immunosuppressive therapy.
Libtayo® (cemiplimab) Approved by the European Commission as the First Immunotherapy Indicated for Patients with Advanced Basal Cell Carcinoma
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved the PD-1 inhibitor Libtayo® to treat adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.
Libtayo® (cemiplimab) Approved by the European Commission for First-Line Treatment of Patients with Advanced Non-small Cell Lung Cancer with ≥50% PD-L1 Expression
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved the PD-1 inhibitor Libtayo® for the first-line treatment of adults with non-small cell lung cancer whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
Sanofi: Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
The European Commission has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo® for the first-line treatment of adults with non-small cell lung cancer whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
Sanofi: Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
The European Commission has approved Sanofi and Regeneron’s PD-1 inhibitor Libtayo® to treat adults with locally advanced or metastatic basal cell carcinoma who have progressed on or are intolerant to a hedgehog pathway inhibitor.
Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma
Approval based on CheckMate -743 trial results showing that Opdivo plus Yervoy significantly increased overall survival vs. standard-of-care chemotherapy – the first positive Phase 3 trial of an immunotherapy in this patient population
AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
AbbVie announced that the European Commission has approved VENCLYXTO® in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.1 The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.
Astellas' XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer
Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types of advanced prostate cancer
GW Pharmaceuticals receives European Commission approval for EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
TSC causes epilepsy in up to 85% of patients, and up to 60% of those patients do not respond to standard anti-epileptic medicines
Amarin Commences Commercial Initiatives for VAZKEPA in European Union Following Recent Regulatory Approval for Cardiovascular Risk Reduction Indication
Amarin Corporation plc provided updates regarding its plans for the commercial launch of VAZKEPA in Europe following the March 30, 2021 announcement of receipt of market authorization from the European Commission.
Passage Bio Receives European Commission Orphan Designation for PBKR03 for Treatment of Krabbe Disease
Passage Bio, Inc., a clinical-stage genetic medicines company focused on developing transformative therapies for rare monogenic central nervous system disorders, announced that the European Commission has granted Orphan designation for PBKR03, an adeno-associated virus -delivery gene therapy for the treatment of Krabbe disease.
Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
Approval based on CheckMate -9ER trial, in which CABOMETYX in combination with OPDIVO doubled progression-free survival and objective response rate while significantly improving overall survival versus sunitinib
European Commission Approves Cabometyx® in Combination With Opdivo® as a First-Line Treatment for Patients Living With Advanced Renal Cell Carcinoma
Ipsen announced that the European Commission has approved Cabometyx® in combination with Bristol Myers Squibb’s Opdivo® for the first-line treatment of advanced renal cell carcinoma.
PTC Therapeutics Announces the European Approval of Evrysdi™ for the Treatment of Spinal Muscular Atrophy
PTC Therapeutics, Inc. announced that the European Commission has granted marketing authorization to Evrysdi™ for the treatment of spinal muscular atrophy in patients 2 months and older.