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News about "European Commission Approval"
EU Expands Trodelvy Use in First-Line Metastatic Triple-Negative Breast Cancer
The European Commission (EC) approves Trodelvy plus pembrolizumab for first-line PD-L1-positive metastatic Triple-Negative Breast Cancer (TNBC), expanding its use across PD-L1 status.
European Commission Approval | 25/08/2026 | By News Bureau
EU Approves DAYBU (Trofinetide) for Rett Syndrome
The European Commission (EC) approves DAYBU (trofinetide) as the first and only treatment for Rett syndrome neurobehavioral symptoms across the European Union (EU) and EEA.
European Commission Approval | 24/08/2026 | By News Bureau
EC Approves Bavarian Nordic's Mpox Vaccine for Children
European Commission (EC) approves Bavarian Nordic's MVA-BN mpox/smallpox vaccine for children aged 2-11 years, expanding protection against mpox, smallpox and vaccinia.
European Commission Approval | 07/08/2026 | By News Bureau
European Commission Expands Sanofi's MenQuadfi Approval to Include Infants from Six Weeks of Age
The European Commission has approved an expanded indication for Sanofi's MenQuadfi vaccine, allowing immunisation of infants from six weeks of age against invasive meningococcal disease caused by serogroups A, C, W and Y.
European Commission Approval | 05/08/2026 | By News Bureau
AbbVie Wins EU Approval for TEPKINLY in Combination with Lenalidomide and Rituximab
The European Commission has approved AbbVie's TEPKINLY with lenalidomide and rituximab as the first bispecific, chemotherapy-free treatment for Relapsed or Refractory Follicular Lymphoma in the second-line setting.
European Commission Approval | 07/07/2026 | By News Bureau
Novartis Secures European Commission Approval for Itvisma in SMA
The European Commission (EC) has approved Novartis' Itvisma, the first gene replacement therapy in the European Union (EU) for a broad population with spinal muscular atrophy (SMA), including children, adolescents, and adults.
European Commission Approval | 03/07/2026 | By News Bureau
CHMP Recommends Lilly's Jaypirca for CLL Treatment in EU
CHMP has recommended Lilly’s Jaypirca (pirtobrutinib) for EU approval in adults with chronic lymphocytic leukemia (CLL), potentially expanding its use across all lines of therapy.
European Commission Approval | 29/06/2026 | By News Bureau
The European Commission has approved Padcev in combination with Keytruda as the first perioperative treatment for cisplatin-ineligible patients with resectable muscle-invasive bladder cancer in Europe.
European Commission Approval | 25/06/2026 | By News Bureau
The European Commission has approved Trodelvy for first-line treatment of unresectable or metastatic triple-negative breast cancer, offering a new therapeutic option for patients with one of the most aggressive forms of breast cancer.
European Commission Approval | 25/06/2026 | By News Bureau | 102
Chiesi Global Rare Diseases Announces EC Approval of Lojuxta Capsules
Chiesi Global Rare Diseases has secured European Commission approval for Lojuxta (lomitapide) in children aged 5 years and older with Homozygous Familial Hypercholesterolaemia (HoFH), expanding treatment options for this ultra-rare genetic cholesterol disorder across the EU.
European Commission Approval | 08/06/2026 | By News Bureau
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