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 tachycardia when the FDA issued a Complete Response Letter on Friday.

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

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 ...

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 ...

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 ...

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 ...

"We are focused on the potential FDA approval for CARDAMYST and the opportunity to help the millions of patients suffering from PSVT,” said Joseph Oliveto, President and Chief Executive Officer ...

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 ...