Milestone said that the FDA did not raise any concerns with Cardamyst’s clinical safety or efficacy. The company opened the year with cash and cash equivalents of $70 million. With an approval ...

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 ...

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.

has also sought additional data on nitrosamine impurities based on new guidance issued after Milestone submitted its application for Cardamyst's approval. Nitrosamine impurities may increase the ...

In addition, Milestone will be entitled to $75 million in royalty payment on FDA approval of Etripamil. RTW also owns 6 million shares of MIST and will have ownership of another 8 million shares ...

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

This marks a key milestone as the Company prepares to initiate its FDA-approved Phase I/IIa clinical ... are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange ...

Milestone, which was seeking FDA approval of etripamil for the conversion of acute episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults, said the agency raised two issues ...