Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular Tachycardia [Yahoo! Finance]
Milestone Pharmaceuticals Inc. - Common Shares (MIST)
Last milestone pharmaceuticals inc. - common shares earnings: 3/6 07:00 am
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Source: Yahoo! Finance
on the development and commercialization of innovative cardiovascular medicines, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for etripamil, the Company's lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). “We appreciate FDA's guidance through the resubmission process. We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the Agency as it reviews our application,” said Joseph Oliveto, President, and Chief Executive Officer of Milestone Pharmaceuticals. “If approved, we believe that etripamil nasal spray will be a valuable treatment option for patients suffering from PSVT.” The NDA for etripamil was resubmitted based on guidance from the FDA obtained in a Type A meeting, which was conducted after receipt of a Refusal to File (RTF) letter. The resubmission package included restructured data sets that captured
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News
- Milestone® Pharmaceuticals to Present Data on Etripamil at the Preventative Cardiovascular Nursing Symposium [Yahoo! Finance]Yahoo! Finance
- Milestone® Pharmaceuticals to Present Data on Etripamil at the Preventative Cardiovascular Nursing SymposiumGlobeNewswire
- Milestone® Pharmaceuticals Announces Etripamil Data Demonstrating Patients' Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Milestone® Pharmaceuticals Announces Etripamil Data Demonstrating Patients’ Ability to Self-Manage Recurring PSVT, Presented at The American College of Cardiology Annual MeetingGlobeNewswire
- Milestone® Pharmaceuticals to Present at the 23rd Annual Needham Healthcare ConferenceGlobeNewswire
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- 3/21/24 - Form 8-K
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