"MannKind Corp.’s inhaled diabetes treatment won the backing of a panel of U.S. regulatory advisers, boosting the company’s long-running effort to get its first product on the market. Shares more than doubled in extended trading Tuesday after the panel’s recommendation.
Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation. FDA staff raised concerns in a report March 28 that the drug may affect lung function and about missing data from a study on Type 1 diabetes patients."
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