Shares of Milestone Pharmaceuticals Inc. (MIST) traded 60% lower on Friday after the Food and Drug Administration (FDA) did not approve its lead investigational product, Cardamyst. The nasal spray is ...

Milestone Pharmaceuticals MIST recently announced that the FDA has issued a Complete Response Letter (“CRL”) for its New Drug ...

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 inspection of the facility that ...

The forward-looking statements point to various risks and uncertainties that could affect the approval of the NDA for CARDAMYST and the company's ability to raise additional capital, which could ...

Now the wait will be longer for its first FDA approval as the regulator has rejected its application for Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular ...

“We are deeply disappointed by the CRL but remain committed to the potential of CARDAMYST as a novel treatment option that can help patients with PSVT. Our team is evaluating the feedback ...

FDA requests additional info on nitrosamine impurities and facility inspection for Milestone's CARDAMYST NDA, delaying approval. Milestone Pharmaceuticals plans to request a Type A meeting with ...

The letter did not raise any concerns regarding clinical safety or efficacy data. The Food and Drug Administration (FDA) has issued a Complete Response Letter to Milestone Pharmaceuticals ...

Milestone Pharmaceuticals MIST recently announced that the FDA has issued a Complete Response Letter (“CRL”) for its New Drug Application (“NDA”) seeking approval for CARDAMYST (etripamil ...