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

This is great news, but families can't just hand over the nasal spray form to their school nurse. The Texas law allowing ...

H.C. Wainwright keeps a Buy rating on Milestone Pharmaceuticals (MIST) after the company announced receipt of a complete response letter from the FDA regarding its new drug application for its ...

Milestone Pharmaceuticals' nasal spray etripamil fails FDA approval for PSVT due to CMC issues, sending shares down 60%. Drug ...

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, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 ...

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 ...

Milestone (WA: MMD )’s President and CEO, Joe Oliveto, expressed the company’s disappointment with the CRL but reaffirmed their commitment to CARDAMYST as a potential novel treatment for PSVT. The ...

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 Pharmaceuticals (MIST) announced the U.S. Food and Drug Administration, FDA, issued a Complete Response Letter, CRL, regarding its ...

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, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 ...