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

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 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 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 ...

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

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 ...