News about "European Commission "

Novartis Secures EC Approval for First Oral Targeted CSU Drug Rhapsido

Novartis introduces Rhapsido in Europe, offering a first-of-its-kind oral targeted therapy for patients with chronic spontaneous urticaria.

European Commission | 28/04/2026 | By News Bureau

European Commission Approves Dupixent for Young Children with Chronic Spontaneous Urticaria

The European Commission has expanded approval of Dupixent to children aged 2–11 with chronic spontaneous urticaria, offering a targeted treatment for those unresponsive to standard antihistamines.

European Commission | 15/04/2026 | By News Bureau

Lupin Secures European Commission Approval for Ranluspec, Biosimilar Ranibizumab

European Commission clears Lupin’s biosimilar ranibizumab, Ranluspec, for multiple retinal disorders; Sandoz to commercialise across the EU, expanding access to affordable biologics.

European Commission | 24/02/2026 | By News Bureau |  125

GSK Wins EU Approval for Exdensur in Severe Asthma and CRSwNP

European Commission clears twice-yearly depemokimab for type 2 inflammation-driven severe asthma and chronic rhinosinusitis with nasal polyps, backed by positive Phase III SWIFT and ANCHOR data.

European Commission | 18/02/2026 | By News Bureau |  130

STADA and Bio-Thera Secure EU Marketing Approval for Golimumab Biosimilar Gotenfia

European Commission authorises Gotenfia, referencing Simponi, for multiple autoimmune diseases across EU and EEA markets.

European Commission | 16/02/2026 | By News Bureau |  161

European Commission Expands Bracco's Vueway Approval to Infants and Neonates

Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.

European Commission | 28/01/2026 | By News Bureau |  132

AGC Biologics' Milan Facility Supports Commercial Launch of Waskyra Gene Therapy After US FDA and EU Approval

AGC Biologics’ Milan Cell and Gene Centre of Excellence will support the commercial rollout of Waskyra following US FDA and EU approvals, strengthening treatment options for patients with Wiskott-Aldrich syndrome.

European Commission | 22/01/2026 | By News Bureau |  158

European Commission Approves Teizeild to Delay Onset of Type 1 Diabetes

Teizeild (teplizumab) becomes the first disease-modifying therapy approved in the EU to delay progression to stage III type 1 diabetes in eligible adults and children aged eight and above.

European Commission | 13/01/2026 | By News Bureau |  229

Samsung Bioepis Launches BYOOVIZ Biosimilar in Europe

Samsung Bioepis has completed the transfer of BYOOVIZ commercial rights from Biogen, making it the company’s fourth biosimilar directly marketed in Europe, with a pre-filled syringe launch planned for Q2 2026.

European Commission | 03/01/2026 | By News Bureau |  147

Gobivaz, First Simponi Biosimilar, Wins EEA Approval

Alvotech, a global biotechnology company focused on biosimilars, and Advanz Pharma, a UK-based pharmaceutical company specializing in specialty and hospital medicines, announced that the European Commission has granted marketing authorizations for Gobivaz, Alvotech’s biosimilar to Simponi (golimumab).

European Commission | 23/11/2025 | By Darshana |  200