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

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

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.

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 ...

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, ...

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

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

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 ...

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 ...

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 ...

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 ...