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) nasal spray ...

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 ...

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 ...

“2025 is set to be a transformative year for Milestone as we prepare for potential FDA approval of CARDAMYST and the opportunity to empower patients suffering with PSVT to self-manage episodes ...

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 ...