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Keeping Track: Chiesi Breathes Easier With Bronchitol Approval; Submissions Aplenty From GSK, Pfizer, AZ, AbbVie

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge

The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.

'Sakigake' Treatment Gives Enhertu Rapid Japan OK For Gastric Cancer

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