U.S. Food and Administration (FDA)

March 19, 2020March 19, 2020

FDA Grants Orphan Drug Status to Umbralisib for Follicular Lymphoma

News

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TG Therapeutics‘ investigational oral therapy umbralisib for the treatment of follicular lymphoma (FL). The status, which follows another ... Read more

August 23, 2019

FDA Grants Priority Review to Zanubrutinib as Treatment for Mantle Cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) has accepted for review BeiGene‘s application requesting the approval of zanubrutinib for treating people with mantle cell lymphoma who received at least one ... Read more

January 17, 2019

FDA Grants Breakthrough Therapy Designation to Zanubrutinib for Mantle Cell Lymphoma

News

The U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to BeiGene’s zanubrutinib as a treatment candidate for adults with mantle cell lymphoma (MCL) who have received at least ... Read more

November 15, 2016

FDA Grants Breakthrough Therapy Designation to Adcetris for Certain Lymphoma Subtypes

News

The U.S. Food and Administration (FDA) has granted Breakthrough Therapy Designation to Seattle Genetics’ Adcetris (brentuximab vedotin) as a therapy for the most common subtypes of cutaneous T-cell lymphoma (CTCL), ... Read more