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Results For "European-Union"

255 News Found

EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy
News | January 17, 2026

EU clears Eylea 8 mg for retinal vein occlusion, expanding use of long-acting eye therapy

Treatment typically requires frequent injections directly into the eye—an ongoing burden for patients and health systems alike


Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera
News | January 11, 2026

Nxera secures exclusive APAC rights to DMD drug Vamorolone in deal with Santhera

Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories


Wockhardt files marketing authorisation application for WCK 5222 with EMA
News | January 08, 2026

Wockhardt files marketing authorisation application for WCK 5222 with EMA

WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation


Valneva and Serum Institute end chikungunya vaccine partnership
News | January 06, 2026

Valneva and Serum Institute end chikungunya vaccine partnership

Valneva said regaining full rights to the vaccine will allow the company to “assume direct control over its supply chain and commercialization for endemic high-risk countries


Caplin Point Labs acquires 10 ANDAs, targets $473M US market
News | January 03, 2026

Caplin Point Labs acquires 10 ANDAs, targets $473M US market

The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025


FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity


Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch
News | December 21, 2025

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026


Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Drug Approval | December 18, 2025

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion