Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced on Friday that its New Drug Application for CARDAMYST (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia, received a Complete Response Letter from the U.S. Food and Drug Administration (FDA).
The company’s shares are trading lower following the news.
While the FDA did not raise concerns about the clinical safety or efficacy of etripamil, it highlighted two critical issues related to Chemistry, Manufacturing, and Controls.
The FDA requested additional information …
Full story available on Benzinga.com
Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced on Friday that its New Drug Application for CARDAMYST (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia, received a Complete Response Letter from the U.S. Food and Drug Administration (FDA).
The company’s shares are trading lower following the news.
While the FDA did not raise concerns about the clinical safety or efficacy of etripamil, it highlighted two critical issues related to Chemistry, Manufacturing, and Controls.
The FDA requested additional information …
Full story available on Benzinga.com
Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced on Friday that its New Drug Application for CARDAMYST (etripamil) nasal spray, aimed at treating acute episodes of paroxysmal supraventricular tachycardia, received a Complete Response Letter from the U.S. Food and Drug Administration (FDA).
The company’s shares are trading lower following the news.
While the FDA did not raise concerns about the clinical safety or efficacy of etripamil, it highlighted two critical issues related to Chemistry, Manufacturing, and Controls.
The FDA requested additional information …Full story available on Benzinga.com Read MoreAI Generated, Briefs, Equities, MIST, News, Regulations, Stories That Matter, why it’s moving, Health Care, Top Stories, Markets, Movers, General, MIST, News, Equities, Regulations, Health Care, Top Stories, Markets, Movers, General, Benzinga Markets
