Axicabtagene Ciloleucel Approved for Relapsed/Refractory Follicular Lymphoma
The FDA has approved axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory indolent follicular lymphoma (FL) who have received two...
FDA Grants Breakthrough Therapy Designation to Asciminib for CML
The FDA has granted breakthrough therapy designation to asciminib, a first-in-class allosteric inhibitor specifically targeting the ABL myristoyl pocket (STAMP), for the treatment of...
Melphalan Flufenamide Receives Accelerated Approval for Relapsed/Refractory Multiple Myeloma
Melphalan flufenamide, in combination with dexamethasone, has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory multiple...
FDA Accepts sNDA for Zanubrutinib in Waldenström Macroglobulinemia
The FDA has accepted a supplemental new drug application (sNDA) for zanubrutinib for the treatment of adults with Waldenström macroglobulinemia (WM).
The sNDA, submitted by...
FDA to Reevaluate Six Accelerated Approvals of Cancer Treatments
The U.S. Food and Drug Administration (FDA) has announced plans to hold a public meeting of its Oncologic Drugs Advisory Committee from April 27...
Fewer Patients Screened for or Diagnosed With Cancer Amid Pandemic
The effects of the COVID-19 pandemic have delayed critical cancer screening appointments such as mammograms and colonoscopies, meaning patients with cancer remain undiagnosed or...
Benefits of AstraZeneca’s COVID-19 Vaccine Outweigh Clotting Risk, Regulatory Agencies Say
Following reports of an unusual increase in cerebral sinus venous blood clots and one death associated with the COVID-19 vaccine developed by AstraZeneca and...
Scientists Say LentiGlobin Not Linked to Cancer
On February 24, the U.S. Food and Drug Administration (FDA) placed a clinical hold on all LentiGlobin gene therapy trials following an announcement that...
Kronos Bio Announces Phase III Trial of Entospletinib in NPM1-Mutated AML
Kronos Bio says it has reached an agreement with the U.S. Food and Drug Administration (FDA) to launch a phase III clinical trial evaluating...
FDA Launches Data Modernization Action Plan
The U.S. Food and Drug Administration (FDA) has launched its Data Modernization Action Plan to update how it handles and uses its large amount...
Current Issue
April 2021 Volume 7 Issue 5
This issue examines long-haul COVID-19, central nervous system relapse in non-Hodgkin lymphoma, and more.