Isatuximab-irfc Approved for Multiple Myeloma
The FDA has approved the anti-CD38 monoclonal antibody isatuximab-irfc, in combination with pomalidomide and dexamethasone, for adults with multiple myeloma (MM) who have received...
FDA Updates Blood Donor Eligibility Guidelines
To help address the need for blood donations amid the COVID-19 outbreak, the FDA has expanded blood donor eligibility guidelines. These guideline changes were...
Luspatercept-aamt Approved for Anemia in Adults With MDS
The FDA has approved luspatercept-aamt for the treatment of anemia that requires 2 or more red blood cell transfusions over 8 weeks in adults...
FDA Approves Coagulation Factor VIIa (Recombinant)-jncw for Hemophilia
The FDA has approved coagulation factor VIIa (recombinant)-jncw to control bleeding in patients aged 12 years and older with hemophilia A or B with...
FDA Grants Breakthrough Designation to APR-246 for MDS
The FDA granted breakthrough therapy designation to APR-246 in combination with azacitidine for the treatment of patients with myelodysplastic syndromes (MDS) and a TP53...
FDA Asks Manufacturer to Withdraw Diet Drug Over Cancer Risk
The FDA issued a safety communication asking Eisai Co. to voluntarily recall its weight management drug lorcaserin, a selective activator of 5-HT2C serotonin receptors...
Tazemetostat Granted Priority Review for Relapsed/Refractory Follicular Lymphoma
The FDA granted a priority review to the new drug application (NDA) for tazemetostat for the treatment of patients with relapsed or refractory follicular...
CAR T-Cell Therapy KTE-X19 Granted Priority Review for MCL
The FDA granted priority-review designation to the investigational chimeric antigen receptor (CAR) T-cell therapy KTE-X19 for the treatment of adults with relapsed or refractory...
2021 Budget Proposal Cuts Funding for CDC, NIH, and CMS
The Trump administration issued its proposed budget for the 2021 fiscal year, which contains substantial cuts to several federal health-care agencies, including the Centers...
FDA Grants Belantamab Mafodotin Priority Review for Myeloma
The FDA granted priority review to the biologics license application of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma...
Current Issue
May 2020, Volume 6, Issue 6
This issue discusses AI's potential to improve patient care, debates using donors with clonal hematopoiesis for alloHCT, and more.
