Will the FDA Crack Down on Clinical Trial Reporting Noncompliance?
The FDA has issued its first notice of noncompliance to Acceleron Pharma for failing to submit clinical trial results to ClinicalTrials.gov, the federal government’s...
Medicare Sequestration Delay Extended Through 2021
Following Senate approval, the U.S. House of Representatives voted 384-38 in favor of continuing to delay the return of Medicare sequestration through December 31....
Beam Therapeutics Develops Inlaid Base Editing Technique for SCD
Beam Therapeutics is testing a new form of CRISPR-based technology called inlaid base editing to modify cells from patients with sickle cell disease (SCD).
Base...
LentiGlobin Not Linked to Cancer, Scientists Say
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 two participants with...
FDA to Reevaluate Six Accelerated Approvals of Cancer Treatments
The FDA held a public meeting of its Oncologic Drugs Advisory Committee in late April to reevaluate six treatments that were previously granted accelerated...
FDA Deputy Commissioner and CIO Amy Abernethy Resigns
Amy Abernethy, MD, PhD, has announced her resignation from her roles as principal deputy commissioner and acting chief information officer at the FDA.
Two years...
Idecabtagene Vicleucel Approved for Relapsed or Refractory Multiple Myeloma
The FDA has approved idecabtagene vicleucel (ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy for the treatment of...
Trilaciclib Approved for Chemotherapy-Induced Myelosuppression
The U.S. Food and Drug Administration (FDA) has approved trilaciclib, a cyclin-dependent kinase 4/6 inhibitor, to reduce the frequency of bone marrow suppression in...
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...
Current Issue
June 2021 Volume 7 Issue 7
This issue reviews the management and prevention of peripheral neuropathy, early successes of SCD screening programs in sub-Saharan Africa, and more.