The Food and Drug Administration has turned away a proposed nasal spray from Milestone Pharmaceuticals to treat a type of irregular heartbeat over concerns about how the drug is manufactured.

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

Milestone in 2023 agreed to sell a royalty interest in etripamil to RTW Investments for $75 million, subject to the company receiving FDA approval of the drug by the end of September 2025. Write to ...

Etripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and ...

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

Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has been a ...

after the company announced receipt of a complete response letter from the FDA regarding its new drug application for its etripamil nasal spray for the treatment of paroxysmal supraventricular ...

The Food and Drug Administration has turned away a proposed nasal spray from Milestone Pharmaceuticals ... complete response letter for the drug, etripamil, indicating the agency won't approve ...

CRL focused on CMC; no clinical issues relating to etripamil raised$69.7M in cash, cash equivalents and short-term investments as of December 31, ...

H.C. Wainwright keeps a Buy rating on Milestone Pharmaceuticals (MIST) after the company announced receipt of a complete response letter from ...