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 ...

A retrospective analysis from Israel suggested that markers of poor hydration are linked to increased risks of hypertension ...

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 ...

(RTTNews) - Milestone Pharmaceuticals (MIST) announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in ...

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 ...

Joe Oliveto, President and CEO of Milestone Pharmaceuticals, expressed disappointment over the CRL but reaffirmed the company’s commitment to CARDAMYST as a potential novel treatment for ...