US FDA breakthrough therapy designation was granted based on data from the company's MZL subgroup of the pivotal Phase II study 16439 part B (CHRONOS-1), where Aliqopa showed preliminary efficacy in indolent non-Hodgkin's lymphoma (iNHL
) patients including 23 patients with relapsed or refractory MZL, who have received at least two prior therapies.
Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Monday the acceptance by the US Food and Drug Administration (FDA) for review the company's New Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of PI3K delta, for the treatment of refractory indolent non-Hodgkin's lymphoma (iNHL
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M2 EQUITYBITES-December 9, 2013-Gilead Sciences Inc announces encouraging results of study 101-09 evaluating idelalisib in indolent non-Hodgkin's lymphoma (iNHL
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Verastem is currently developing duvelisib, a dual inhibitor of PI3K-delta and PI3K-gamma, which has successfully met its primary endpoint in a Phase 2 study in iNHL
and is currently being evaluated in a Phase 3 clinical trial in patients with CLL.
(NYSE:TEVA) announced on Wednesday the grant of orphan drug exclusivity for TREANDA by the US Food and Drug Administration (FDA) through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL
) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
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