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Mylan NV

www.mylan.com

Latest From Ocular Therapeutix Inc.

Keeping Track Of CRLs: US FDA Again Faults Bausch + Lomb Manufacturing

A look at recent developments tracked by the Complete Response Letters chart on the Pink Sheet's US FDA Performance Tracker.

Complete Response Letters Regulation

Ocular Analyzes Particulates Root Cause After Whiffing With Steel Blade

Ocular takes another swing at resolving the manufacturing issues that resulted in a complete response letter for its Dextenza.

Manufacturing Quality

Keeping Track: Tremfya Clears FDA; Dextenza Amendment Is Too Late; Emicizumab, Abemaciclib Filed

The latest drug development news and highlights from our US FDA Performance Tracker.

Regulation Research & Development

Does Ocular's Latest CRL Mean A Minor Delay For Dextenza, Or A New NDA?

The biotech sought a three-month action date extension with new manufacturing process data submitted to FDA just one day before the complete response letter.

Complete Response Letters Manufacturing
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