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US FDA Declines to Approve Milestone's Heart Rhythm Nasal Spray; Shares Halve

Summary by Medscape
Milestone Pharmaceuticals said on Friday the U.S. health regulator had declined to approve its nasal spray to treat a type of heart condition and had called for an... Reuters Health Information

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cardiovascularbusiness.comcardiovascularbusiness.com

FDA chooses not to approve new nasal spray for heart rhythm issues

Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals.

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Endpoints NewsEndpoints News

Milestone's shares dive after FDA again rejects drug for abnormal heart rhythm

Milestone Pharmaceuticals’ nasal spray failed for a second time to secure US approval to treat an arrhythmia disorder called paroxysmal supraventricular tachycardia. The FDA’s complete response letter identified two CMC issues, according to Friday's ...

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hcplive.comhcplive.com

FDA Issues CRL for Etripamil Nasal Spray (Cardamyst) in PSVT

Announced on March 28, 2025, the FDA's CRL to Milestone Pharmaceuticals cites CMC issues, but no issues with safety or efficacy data.

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MedscapeMedscape

US FDA Declines to Approve Milestone's Heart Rhythm Nasal Spray; Shares Halve

Milestone Pharmaceuticals said on Friday the U.S. health regulator had declined to approve its nasal spray to treat a type of heart condition and had called for an... Reuters Health Information

·United States
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Medscape broke the news in United States on Friday, March 28, 2025.
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