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Reposted
The Advisory Committee voted 10–6 in favor of granting full approval for elamipretide.
Patients and families saw the AdComm’s endorsement as an encouraging sign because the FDA almost always follows its recommendation.
www.youtube.com/watch?v=guVE...
Patients and families saw the AdComm’s endorsement as an encouraging sign because the FDA almost always follows its recommendation.
www.youtube.com/watch?v=guVE...
October 10, 2024 Meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)
YouTube video by U.S. Food and Drug Administration
www.youtube.com
June 23, 2025 at 9:21 PM
The Advisory Committee voted 10–6 in favor of granting full approval for elamipretide.
Patients and families saw the AdComm’s endorsement as an encouraging sign because the FDA almost always follows its recommendation.
www.youtube.com/watch?v=guVE...
Patients and families saw the AdComm’s endorsement as an encouraging sign because the FDA almost always follows its recommendation.
www.youtube.com/watch?v=guVE...
Reposted
But last month, it didn’t.
Despite the AdComm’s positive endorsement—and despite the Trump administration’s stated commitment to accelerating therapies for rare diseases—the FDA rejected approval for elamipretide.
Despite the AdComm’s positive endorsement—and despite the Trump administration’s stated commitment to accelerating therapies for rare diseases—the FDA rejected approval for elamipretide.
June 23, 2025 at 9:21 PM
But last month, it didn’t.
Despite the AdComm’s positive endorsement—and despite the Trump administration’s stated commitment to accelerating therapies for rare diseases—the FDA rejected approval for elamipretide.
Despite the AdComm’s positive endorsement—and despite the Trump administration’s stated commitment to accelerating therapies for rare diseases—the FDA rejected approval for elamipretide.