Fast Track Pathway May Be ‘Poor Man’s Breakthrough’ But It Works
Most requests for the FDA’s less-heralded expedited review designation are based on Phase II or earlier data, and have a greater chance of success than requests for breakthrough designation.
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Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval
Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.
Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy
Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.