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News about "EU Approval "
EU Approves Sanofi's MenQuadfi for Invasive Meningococcal Disease
Sanofi's MenQuadfi has received European Union (EU) approval for infants from 6 weeks of age, expanding protection against invasive meningococcal disease.
EU Approval | 04/08/2026 | By News Bureau
EU Approves Datroway for First-Line Metastatic TNBC
The European Union (EU) has approved AstraZeneca and Daiichi Sankyo's Datroway for first-line metastatic Triple Negative Breast Cancer (TNBC), backed by positive phase 3 survival and PFS results.
EU Approval | 01/08/2026 | By News Bureau | 121
EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab
If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.
EU Approval | 25/07/2026 | By News Bureau
CHMP Recommends AstraZeneca's Trixeo for EU Approval in Asthma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU approval of AstraZeneca's Trixeo for asthma maintenance, backed by positive phase 3 KALOS and LOGOS trial results.
EU Approval | 25/07/2026 | By News Bureau | 154
CHMP Recommends EU Approval of Roche's Susvimo
The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Roche's Susvimo, the first continuous delivery treatment offering an alternative to regular eye injections for wet Age-related Macular Degeneration (AMD).
EU Approval | 25/07/2026 | By News Bureau | 100
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 | 103
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 | 108
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 | 128
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 | 389
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