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News about "European Commission Approval"
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
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
EU Approves AQUIPTA for Acute Migraine Treatment in Adults
The EC has approved AQUIPTA (atogepant) for the acute treatment and prevention of migraine in adults, based on phase 3 ECLIPSE trial results demonstrating rapid pain relief, sustained efficacy, and consistent benefits across multiple migraine attacks. The approval expands AbbVie’s migraine treatment portfolio across EU.
European Commission Approval | 03/06/2026 | By News Bureau
Pharming Secures EU Approval for Joenja as First Targeted Treatment for Rare Immune Disorder APDS
Pharming Group has received European Commission approval for Joenja, expanding treatment access for patients with activated PI3K delta syndrome and strengthening therapeutic options for rare immune disorders.
European Commission Approval | 26/05/2026 | By News Bureau
Pfizer Secures EC Approval to Expand Hympavzi Use for Haemophilia Patients with Inhibitors
Pfizer has secured European Commission approval to expand the use of Hympavzi for haemophilia A and B patients with inhibitors, offering a once-weekly subcutaneous treatment option designed to reduce bleeding episodes and improve disease management.
European Commission Approval | 14/05/2026 | By News Bureau
Bristol Myers Squibb Secures EC Approval for Sotyktu in Psoriatic Arthritis
Bristol Myers Squibb receives European Commission (EC) approval for Sotyktu to treat active psoriatic arthritis in adults, marking the EU’s first approved TYK2 inhibitor for this indication.
European Commission Approval | 12/05/2026 | By News Bureau | 109
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