European Commission (EC)

329 articles about European Commission (EC)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Press Release: Dupixent® (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis 

  3/21/2023

  The European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.

• Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis

  3/21/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.

• Darolutamide receives EU approval for additional indication in prostate cancer

  3/1/2023

  The European Commission has granted marketing authorisation in the European Union for darolutamide, an oral androgen receptor inhibitor, plus androgen deprivation therapy in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer.

• I3LUNG Study to Revolutionize Lung Cancer Treatment Launches Website

  2/2/2023

  The I3LUNG project funded by the European Commission and promoted by MEDSIR, an independent clinical research company in oncology based in Barcelona, the Instituto Nazionale dei Tumori in Milan and other European institutions has launched a new website.

• Poxel Receives Orphan Drug Designation from the European Commission for PXL770 and PXL065 for Treatment of Adrenoleukodystrophy

  1/25/2023

  POXEL SA announced that European Commission has granted orphan drug designation for PXL770 and PXL065 for the treatment of adrenoleukodystrophy.

• ADC Therapeutics and Sobi Announce European Commission Approval of ZYNLONTA® (loncastuximab tesirine) for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

  12/21/2022

  ADC Therapeutics SA and Swedish Orphan Biovitrum AB announced the European Commission has granted conditional marketing authorization for the use of ZYNLONTA® for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

• Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Prurigo Nodularis

  12/15/2022

  Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission has expanded the marketing authorization for Dupixent® in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

• Press Release: Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis

  12/15/2022

  The European Commission has expanded the marketing authorization for Dupixent® in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.