FDA Determines that Afrezza REMS Communication Plan Has Met Goals and REMS No Longer Necessary
MannKind Corporation (MNKD)
Last mannkind corporation earnings: 2/25 08:00 am
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Source: GlobeNewswire
WESTLAKE VILLAGE, Calif., April 25, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD), focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced that the Food and Drug Administration (FDA) has completed its review of a supplemental New Drug Application (sNDA) for Afrezza (insulin human) inhalation powder and has determined that the Risk Evaluation and Mitigation Strategy (REMS) communication plan regarding the risks of Afrezza has been completed and has met its goals. As a result, the FDA has decided that a REMS is no longer required for Afrezza. “We are pleased that the FDA determined that a communication plan is no longer necessary to ensure the benefits of Afrezza outweigh its risks and that a REMS is no longer required,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “We are grateful for the FDA’s guidance and expediency in this process
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News
- MannKind Announces CFO Transition [Yahoo! Finance]Yahoo! Finance
- MannKind CFO Steven Binder to retire [Seeking Alpha]Seeking Alpha
- MannKind Announces CFO TransitionGlobeNewswire
- MannKind Co. (NASDAQ: MNKD) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $6.50 price target on the stock.MarketBeat
- INHALE-3 Study's Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps [Yahoo! Finance]Yahoo! Finance
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- 2/27/24 - Form 8-K
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