UNITY-NHL Phase 2b trial

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

November 8, 2019

Advanced Follicular Lymphoma Patients Show Positive Overall Response to Umbralisib in Phase 2 Trial

News

TG Therapeutics’ umbralisib (TGR-1202), an inhibitor of the PI3K delta protein, has shown promising response rates in patients with relapsed or refractory follicular lymphoma, according to new data from a Phase ... Read more

July 11, 2019

TG Therapeutics to Seek Accelerated Approval of Umbralisib for Marginal Zone Lymphoma

News

After positive feedback from the U.S. Food and Drug Administration, TG Therapeutics is planning to pursue accelerated approval for umbralisib (TGR-1202) as a treatment for patients with marginal zone lymphoma (MZL). ... Read more

April 4, 2019

TG Therapeutics’ Umbralisib Proves Safe, Effective for Previously Treated Marginal Zone Lymphoma

News

TG Therapeutics‘ umbralisib (TGR-1202), an inhibitor of the PI3K delta protein, has shown promising efficacy and safety in patients with relapsed or refractory marginal zone lymphoma, reducing cancer volume in more than half of ... Read more

January 28, 2019

FDA Names Umbralisib ‘Breakthrough Therapy’ as Possible Treatment for Marginal Zone Lymphoma

News

The U.S. Food and Drug Administration (FDA) has designated umbralisib (TGR-1202), by TG Therapeutics, a breakthrough therapy as a possible treatment for adults with marginal zone lymphoma (MZL) who did not respond to at least one ... Read more