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Home » FDA Grants Fast-Track Status to Genta’s, Allon’s Drugs
FDA Grants Fast-Track Status to Genta’s, Allon’s Drugs
April 15, 2010
The FDA
has granted fast-track status to Genta’s gastric cancer treatment tesetaxel and Allon Therapeutics’ neuroprotective drug davunetide.
Genta expects to submit its plan for a randomized, double-blind, placebo-controlled Phase III trial to the FDA in the second quarter, the company said
last week. Genta has completed a dose-ranging and pharmacokinetic study of tesetaxel plus Roche’s Xeloda (capecitabine).
Washington Drug Letter
Washington Drug Letter
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