European Commission (EC)
297 articles with European Commission (EC)
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Moderna And the European Commission (EC) Amend Covid-19 Vaccine Agreement to Supply Omicron-Containing Bivalent Candidates; EC Purchases Additional 15 million Doses
8/8/2022
Moderna, Inc., a biotechnology company pioneering messenger RNA therapeutics and vaccines, announced an amendment to its agreement with the European Commission to convert contractually agreed doses of Moderna's COVID-19 vaccine to the Company's Omicron-containing bivalent vaccines for supply in 2022, pending regulatory approval.
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LYNPARZA® (olaparib) Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer
8/4/2022
AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations, who have human epidermal growth factor receptor 2 -negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
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RINVOQ® (upadacitinib) Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis
7/29/2022
AbbVie announced that the European Commission has approved RINVOQ®, an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging, who have responded inadequately to nonsteroidal anti-inflammatory drugs.
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Everest Medicines Announces European Commission Grants Approval of Kinpeygo® for Adults with Primary IgA Nephropathy to our Partner Calliditas Therapeutics
7/18/2022
Everest Medicines, announced that our partner Calliditas Therapeutics AB has been granted conditional marketing authorization for Kinpeygo® by the European Commission for the treatment of primary immunoglobulin A nephropathy in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio ≥1.5 g/gram.
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Kite’s CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma
6/28/2022
Kite, a Gilead Company, announces that the European Commission has approved its CAR T-cell therapy Yescarta® for the treatment of adult patients with relapsed or refractory follicular lymphoma after three or more lines of systemic therapy.
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Press Release: Xenpozyme® (olipudase alfa) approved by European Commission as first and only treatment for ASMD
6/28/2022
The European Commission has approved Xenpozyme® as the first and only enzyme replacement therapy for the treatment of non-Central Nervous System manifestations of Acid Sphingomyelinase Deficiency in pediatric and adult patients with ASMD type A/B or ASMD type B.
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Press Release: Nexviadyme® (avalglucosidase alfa) approved by European Commission as a potential new standard of care for the treatment of Pompe Disease
6/28/2022
The European Commission has granted marketing authorization for Nexviadyme®, an enzyme replacement therapy for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder.
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European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Adolescent Patients (≥12 Years of Age) With Stage IIB or IIC Melanoma Following Complete Resection
6/24/2022
Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection.
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Day One Biopharmaceuticals announced positive early data assessing tovorafenib as a once-a-week treatment in people aged six months to 25 years with relapsed or progressive pediatric low-grade glioma.
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Moderna and the European Commission Agree on Amendment to COVID-19 Vaccine Supply Agreement
6/2/2022
Moderna, Inc. announced an agreement with the European Commission to amend their originally agreed contractual delivery schedules for the Moderna COVID-19 vaccine booster product or updated booster vaccine candidate.
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TikoMed's contribution to the fight is ILB, a novel patented formulation of a modified glycosaminoglycan that works to tackle ALS through neurotrophic and myogenic effects.
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CARVYKTI® (ciltacabtagene autoleucel) Granted Conditional Approval by the European Commission for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
5/26/2022
Legend Biotech Corporation announced that the European Commission has granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
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Incyte Announces European Commission Approval of Jakavi® (ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease
5/5/2022
Incyte announced the European Commission has approved Jakavi® for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies.
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Ipsen: European Commission Approves Cabometyx® as a Second-Line Treatment for People Living With Radioactive Iodine-Refractory Differentiated Thyroid Cancer
5/3/2022
Ipsen announced that the European Commission has approved the use of Cabometyx® as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.
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Horizon Therapeutics plc Receives European Commission (EC) Approval of UPLIZNA® (inebilizumab) for the Treatment of Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
5/2/2022
Horizon Therapeutics plc announced the European Commission approval of UPLIZNA® as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 immunoglobulin G seropositive, following the positive opinion adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency on 11th November, 2021.
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European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Tumors in Five Different Types of Cancer
4/29/2022
Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of microsatellite instability-high or deficient mismatch repair tumors in adults.
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European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
4/29/2022
Merck, known as MSD outside the United States and Canada, announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1.
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Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
4/28/2022
Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics, Inc. announced that the European Commission has granted marketing authorization to Kapruvia® for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients.
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Pfizer and Biohaven’s VYDURA® (Rimegepant) Granted First Ever Marketing Authorization by European Commission for Both Acute Treatment of Migraine and Prophylaxis of Episodic Migraine
4/27/2022
Pfizer Inc. and Biohaven Pharmaceutical Holding Company Ltd. announced that the European Commission has granted marketing authorization for VYDURA®, a calcitonin gene-related peptide receptor antagonist for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month.
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AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).