FDA Issues Complete Response Letter for Milestone Pharmaceuticals' Etripamil Nasal Spray
The FDA has issued a Complete Response Letter for Milestone Pharmaceuticals' Cardamyst (etripamil) nasal spray, citing chemistry, manufacturing, and controls issues rather than safety or efficacy concerns.
FDA Rejects Milestone's Cardamyst for PSVT, Citing Manufacturing Issues
The FDA has rejected Milestone Pharmaceuticals' nasal spray Cardamyst for paroxysmal supraventricular tachycardia, citing chemistry, manufacturing and controls issues, causing company shares to plummet over 60%.
Milestone Pharmaceuticals Gains New Patent for Etripamil, Prepares for Potential Launch
Milestone Pharmaceuticals received a Notice of Allowance from the USPTO for a new patent covering the repeat dose regimen of etripamil nasal spray, extending potential IP protection to July 2042.
Etripamil Nasal Spray Shows Positive Phase III Results for PSVT Treatment in China
Ji Xing Pharmaceuticals' Phase III trial of etripamil nasal spray met its primary endpoint, showing a statistically significant conversion to normal heart rhythm within 30 minutes compared to placebo.
FDA Accepts Milestone's Cardamyst NDA for PSVT Treatment
The FDA has accepted Milestone Pharmaceuticals' NDA for Cardamyst (etripamil) nasal spray, a potential treatment for paroxysmal supraventricular tachycardia (PSVT).
Milestone Pharmaceuticals Resubmits NDA for Etripamil Nasal Spray for PSVT Treatment
Milestone Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for etripamil nasal spray, a potential treatment for paroxysmal supraventricular tachycardia (PSVT).