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Tuesday, April 24, 2018 6:00:06 PM
MannKind +8% as FDA clears risk hurdles for Afrezza
Apr. 24, 2018 5:37 PM ET|About: MannKind Corporation (MNKD)|By: Jason Aycock, SA News Editor
•MannKind (NASDAQ:MNKD) is up 8.1% after hours following a letter from the FDA saying that the company's Afrezza inhalation treatment no longer needs a Risk Evaluation and Mitigation Strategy.
•"We have determined that the communication plan is no longer necessary as an element of the REMS to ensure the benefits of Afrezza (insulin human) inhalation powder outweigh its risks because the communication plan has been completed and the most recent assessment demonstrated that the communication plan has met its goals," the FDA writes.
•With that, a REMS is no longer required for the powder, the FDA says.
Recent MNKD News
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