MPR21h
FDA Decision on Etripamil Nasal Spray Delayed Due to Nonclinical Issues
The Food and Drug Administration (FDA) has issued a Complete Response Letter to Milestone Pharmaceuticals regarding the New Drug Application (NDA) for ...
FDA Rejects Milestone Pharmaceuticals' Etripamil Nasal Spray
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.
Morningstar5d
FDA Rejects Milestone Pharmaceuticals' Etripamil Nasal Spray
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 ...
FDA Issues Complete Response Letter for Etripamil for PSVT
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 ...
Morningstar5d
FDA Issues Complete Response Letter for Etripamil for PSVT
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 ...
Investing.com Australia5d
Milestone stock tumbles after FDA letter on etripamil
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 ...
Milestone Pharmaceuticals Inc.: FDA Issues Complete Response Letter for Etripamil for PSVT
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 ...