Keeping Track: Seqirus Pandemic Flu Vaccine Approved; Trevena Resubmits Oliceridine
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Formycon Delay Pushes Back Coherus’ Ranibizumab
Formycon and Bioeq’s US filing for a biosimilar ranibizumab rival to Lucentis has been delayed after the FDA requested further data following a manufacturing change. Rights to the biosimilar have been licensed exclusively to Coherus in the US.
Keeping Track: Ayvakit Approval, Keytruda Supplement, NME Submissions
The latest drug development news and highlights from our US FDA Performance Tracker.
Breaking Up With Breakthrough: Trevena And Tonix Lose Designation, But Continue With Pivotal Plans
US FDA rescinds breakthrough designations for Tonix’ PTSD therapy Tonyma and Trevena’s novel pain drug Olinvo after clinical trial disappointments – and after identifying other regulatory pathways to market.