FDA

September 24, 2019

Fate Therapeutics Plans Trials Testing Off-the-shelf NK Cell Therapy for Lymphoma, Leukemia

News

Fate Therapeutics has been cleared by the U.S. Food and Drug Administration (FDA) to initiate clinical studies evaluating FT596, its off-the-shelf cell-based immunotherapy designed to target multiple tumor proteins. The ... Read more

August 1, 2019

Allergan Issues Worldwide Recall of Some Breast Implant Products Due to Lymphoma Risk

News

Allergan has issued a worldwide recall of its BIOCELL textured breast implant products, due to the potential risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The recall — for Allergan’s proprietary ... Read more

July 30, 2019August 26, 2019

FDA Approves Rituxan Biosimilar Ruxience for Non-Hodgkin’s Lymphoma

News

The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), for all non-Hodgkin’s lymphoma indications of its reference product, the company announced. The therapy ... Read more

July 16, 2019

FDA Grants Fast Track Status to Investigational Compound CLR 131 for DLBCL

News

Cellectar Biosciences’ investigational radiotherapeutic compound, CLR 131, has received fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory diffuse large B-cell ... 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

June 13, 2019June 20, 2019

FDA Gives OK to Polivy plus Rituxan-Bendamustine Combo to Treat Advanced DLBCL

News

The U.S. Food and Drug Administration (FDA) has approved — with conditions — Genentech‘s Polivy (polatuzumab vedotin-piiq), used in combination with Rituxan (rituximab) and bendamustine (a chemotherapy), to treat adults with relapsed or ... Read more

May 21, 2019

FDA Won’t Ban Sales of Breast Implants Linked to Lymphoma, But Considers Black Box Warning

News

In announcing that breast implants linked to anaplastic large-cell lymphoma (ALCL) can continue to be sold in the United States, the U.S. Food and Drug Administration (FDA) proposed assurances that the ... Read more

February 22, 2019

FDA OKs Phase 1 Trial to Test TJC4 in Solid Tumors, Lymphoma

News

I-Mab Biopharma is planning the first-in-human U.S. clinical study evaluating the safety, tolerability, and efficacy of its investigational candidate TJC4 as a treatment for solid tumors and lymphoma. The Phase ... Read more

February 14, 2019

FDA Update Shows 457 Cases of ALCL Linked to Breast Implants

News

The number of reported cases of anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) has risen to 457, according to a 2018 update from the U.S. Food and Drug Administration ... Read more

January 31, 2019

FDA Approves Imbruvica-Gazyva Combo for First-line Treatment of CLL/SLL

News

The U.S. Food and Drug Administration has approved a combination of Imbruvica (ibrutinib) and Gazyva (obinutuzumab) for the initial treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). This is the first ... Read more