Milestone Pharmaceuticals faces an FDA setback for its PSVT nasal spray. The company coordinates with regulatory authorities to resolve CRL issues.

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 ...

Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular tachycardia when the FDA issued a Complete Response Letter on Friday.

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 ...

Milestone Pharmaceuticals' stock drops over 61% after receiving a Complete Response Letter from the FDA for its CARDAMYST NDA.

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 ...

CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 ...

Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has been a challenge for Milestone Pharmaceutical in its 22 years. | The FDA has rejected ...

Shares of Milestone Pharmaceuticals Inc. (MIST) traded 60% lower on Friday after the Food and Drug Administration (FDA) did ...