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 ...

Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular ...

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

The facility changed ownership during the review of the NDA. “We are deeply disappointed by the CRL but remain committed to the potential of CARDAMYST as a novel treatment option that can help ...

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 ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter to Milestone Pharmaceuticals regarding the New Drug Application (NDA) for ...

FDA PDUFA review goal date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) Assuming FDA approval, proposed launch in PSVT targeted for ...

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 ...

The company had previously expected to launch the nasal spray, Cardamyst, in mid-2025. The U.S. Food and Drug Administration, in its so-called complete response letter, has also sought additional ...

MONTREAL and CHARLOTTE, N.C., March 13, 2025 (GLOBE NEWSWIRE) -- Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and full year ended ...