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Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA

 
• By Michael Cipriano

US FDA Commissioner Gottlieb defended the decision to clear the controversial opioid in the agency’s press release on the approval, and announced a possible shift in how future opioid applications are reviewed.  

In announcing the US FDA's approval of AcelRx Pharmaceuticals Inc.'s controversial opioid Dsuvia (sufentanil sublingual), Commissioner Scott Gottlieb not only offered the agency's defense of the decision, but also revealed that the agency will be exploring a shift in the paradigm of how it reviews future opioid applications.

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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
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More from Product Reviews

New EU Approvals

 
• By Neena Brizmohun

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US CDC Panel Recommends Some 50-59 Year-Olds For RSV Vaccination

 
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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.