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FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010
FDA issues complete response letter to Outlook Therapeutics for resubmitted BLA for ONS-5010

August 28th 2025

FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.

European Union flags outside a parliament building. Concept image for European Commission approval and European Medicines Agency regulatory decision on aflibercept biosimilar Mynzepli. Image credit: ©artjazz – stock.adobe.com
European Commission approves aflibercept biosimilar Mynzepli

August 21st 2025

FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025
FDA extends target action date for two Regeneron regulatory submissions to Q4 of 2025

August 21st 2025

Opthea parts with CEO, lays off over 80% of company
Opthea parts with CEO, lays off over 80% of company

August 19th 2025

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