US FDA declines to approve Milestone's heart rhythm nasal spray; shares halve
Milestone Pharmaceuticals said on Friday the U.S. health regulator had declined to approve its nasal spray to treat a type of ...
MPR2d
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.
Fierce Pharma2d
Manufacturing issues trip up Milestone's long-awaited FDA landmark
Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has been a ...
Asianet Newsable on MSN2d
Milestone Pharmaceuticals Stock Plunges 60% After FDA Declines To Approve Its Cardamyst Nasal Spray – But Retail’s Positive
Shares of Milestone Pharmaceuticals Inc. (MIST) traded 60% lower on Friday after the Food and Drug Administration (FDA) did ...
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, ...
Nasdaq2d
Milestone Pharma: FDA Issues CRL Regarding New Drug Application For CARDAMYST Nasal Spray
announced the FDA issued a Complete Response Letter regarding its New Drug Application for CARDAMYST nasal spray, a prescription medication in development for the conversion of acute episodes of ...
Fierce Pharma10d
Paratek acquires Optinose, rhinosinusitis spray Xhance in deal worth up to $330M
In a move to expand its portfolio beyond antibiotics, Paratek Pharmaceuticals has bought out Optinose and its chronic ...
Milestone Pharmaceuticals announces FDA issued CRL for etripamil
Milestone Pharmaceuticals (MIST) announced the U.S. Food and Drug Administration, FDA, issued a Complete Response Letter, CRL, regarding its ...
US FDA declines to approve Milestone's heart rhythm nasal spray
Milestone Pharmaceuticals said on Friday that the U.S. health regulator had declined to approve its nasal spray to treat a ...
Morningstar3d
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.