European Commission (EC)
337 articles about European Commission (EC)
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European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease
3/13/2024
Pfizer Inc. announced that the European Commission has granted marketing authorization for the company’s 20-valent pneumococcal conjugate vaccine, marketed in the European Union under the brand name PREVENAR 20®, for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age.
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European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia
2/13/2024
Vertex Pharmaceuticals Incorporated announced that the European Commission has granted conditional marketing authorization to CASGEVY™, a CRISPR/Cas9 gene-edited therapy.
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Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
1/29/2024
Takeda announced that the European Commission approved HYQVIA® [Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy after stabilization with intravenous immunoglobulin therapy.
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Ultragenyx Receives European Commission Decision for Evkeeza® (evinacumab) Expanded Indication in Children Aged 5 Years and Older with Homozygous Familial Hypercholesterolemia (HoFH)
12/18/2023
Ultragenyx Pharmaceutical Inc. announced that the European Commission has extended the approval of Evkeeza® as an adjunct to diet and other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia.
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Astellas' VEOZA™ (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause
12/10/2023
Astellas Pharma Inc. announced the European Commission on December 7 approved VEOZATM 45 mg once daily for the treatment of moderate to severe vasomotor symptoms associated with menopause.
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Ascendis Pharma Announces European Commission Approval of YORVIPATH® (palopegteriparatide) for the Treatment of Adults with Chronic Hypoparathyroidism
11/20/2023
Ascendis Pharma A/S announced that the European Commission has granted marketing authorization for YORVIPATH® as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.
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European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults With Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy
10/16/2023
Merck, known as MSD outside of the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
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Illumina responds to European Commission's divestiture order
10/13/2023
Illumina, Inc., has received an order from the European Commission directing the company to divest GRAIL.
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AbbVie Announces European Commission Approval of TEPKINLY® (epcoritamab) for Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma
9/25/2023
AbbVie announced that the European Commission has granted conditional marketing authorization for TEPKINLY® 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.
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BeiGene Announces Positive Regulatory Updates in Europe and the U.S. After Recently Regaining Global Rights for TEVIMBRA®
9/19/2023
BeiGene, Ltd. announced that the European Commission has approved TEVIMBRA® as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.
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Otsuka and Astex announce that the European Commission has approved INAQOVI® (oral decitabine and cedazuridine) for the treatment of adults with newly diagnosed acute myeloid leukaemia
9/19/2023
Otsuka Pharmaceutical Europe Ltd. and Astex Pharmaceuticals, Inc. announce that the European Commission has approved INAQOVI® as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia who are ineligible for standard induction chemotherapy.
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European Commission Expands Merck’s ERVEBO® [Ebola Zaire Vaccine, (rVSVΔG-ZEBOV-GP) live] Indication to Include Children 1 Year of Age and Older
9/7/2023
Merck, known as MSD outside of the United States and Canada, announced that the European Commission has approved an expanded indication for ERVEBO for active immunization of individuals 1 year of age or older to protect against Ebola Virus Disease caused by Zaire ebolavirus.
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European Commission Approves KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy as First-Line Treatment for HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Expressing PD-L1 (CPS ≥1)
8/29/2023
Merck, known as MSD outside of the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 -positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
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AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Preventive Treatment of Migraine in Adults
8/17/2023
AbbVie announced that the European Commission has approved AQUIPTA® for the prophylaxis of migraine in adults who have four or more migraine days per month.
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Curium Receives Marketing Authorization in the EU for PYLCLARI™, an Innovative 18F-PSMA PET Tracer Indicated in Adults With Prostate Cancer
7/28/2023
Curium announced that the European Commission has granted marketing authorization for PYLCLARI™ indicated for the detection of prostate-specific membrane antigen positive lesions with positron emission tomography in adults with prostate cancer.
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CHMP Recommends Evrysdi® for Babies Under Two Months Old with Spinal Muscular Atrophy
7/21/2023
PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion for the extension of the Evrysdi® marketing authorization to include infants under two months of age in the European Union.
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Fennec Pharmaceuticals Announces European Commission Marketing Authorization for Pedmarqsi™ (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients
6/6/2023
Fennec Pharmaceuticals Inc., a commercial stage specialty pharmaceutical company, announced Pedmarqsi™– known as PEDMARK® in the U.S. – was granted marketing authorization by the European Commission.
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Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce European Commission Authorization of PRX-102 (pegunigalsidase alfa) for the Treatment of Fabry Disease
5/5/2023
Chiesi Global Rare Diseases and Protalix BioTherapeutics, Inc. announced that the European Commission has granted marketing authorization to PRX-102 in the European Union for the treatment of adult patients with Fabry disease.
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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.
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AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Moderately to Severely Active Crohn's Disease
4/17/2023
AbbVie announced the European Commission approved RINVOQ® as the first oral Janus Kinase inhibitor 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.