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Outlook’s Ophthalmic Bevacizumab Knocked Back By FDA

US Agency Offers Multiple Reasons For CRL Over Outlook’s BLA For Lytenava

Executive Summary

Outlook Therapeutics has received a CRL from the US FDA over its application for an ophthalmic formulation of bevacizumab. The company says it is working with the agency to address the various issues raised.

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Outlook Pulls Bevacizumab BLA As Filing Falls Short

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Sandoz Prepares For European Natalizumab Launch As Approval Arrives

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