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News about "EU Approval "
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.
EU Approval | 03/07/2026 | By News Bureau
EU Approves Sanofi's Sarclisa SC as First On-Body Injector Cancer Therapy
Sanofi’s Sarclisa subcutaneous has received EU approval as the first anticancer therapy delivered via an On-Body Injector (OBI). Administered through the CirCLIQ OBI, the treatment offers flexible home or outpatient use for multiple myeloma patients while maintaining efficacy across all approved Sarclisa indications and combinations.
EU Approval | 09/06/2026 | 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.
EU Approval | 03/06/2026 | By News Bureau
CHMP Recommends Sanofi's Tezeild for EU Approval in Stage 2 Type 1 Diabetes
The CHMP has backed EU approval for Sanofi’s Tezeild, supported by TN-10 study results showing the therapy can delay progression to stage 3 type 1 diabetes in patients with stage 2 disease. If authorised, Tezeild would become the first disease-modifying treatment for T1D in the EU.
EU Approval | 15/11/2025 | By Dineshwori | 374
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