FDA accepted Milestone's response to the Complete Response Letter (CRL).
3 reports, 3 independent
Updated Sep 24
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New informationRepeats or wire copies
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What happened
FDA accepted Milestone's response to the Complete Response Letter (CRL).
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Milestone drug receives FDA approval after previous CRL response acceptance.1 source
CRL from FDA prompts sales forecast delay for company associated with Andy Hsieh.1 source
FDA accepted Milestone's response to the CRL on July 11, 2025.1 source
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The entities involved
Related events
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Coverage
Newest first; wire copies grouped- manilatimes.net
- benzinga.com
- GlobeNewswireMilestone Pharmaceuticals Announces FDA Acceptance of the Company’s Response to the CRL for CARDAMYST™ (etripamil) Nasal Spray New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase