US FDA issues a CRL for the biologics license application for bevacizumab

Biocon

12 February 2023 - The US FDA has issued a complete response letter for the biologics license application for bevacizumab filed by our partner Viatris (Mylan). 

The complete response letter informs the need for a satisfactory resolution of the observations made during the facility inspection conducted in August, 2022.

Read Biocon statement

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier