Oliceridine Approved for Management of Acute Pain
Oliceridine, a parenterally administered μ-receptor opioid agonist, is approved for the management of moderate to severe acute pain in adults requiring an intravenous (IV)...
New “Buy American” Order Mandates Domestic Manufacturing of Essential Drugs
President Donald Trump signed a new executive order requiring that certain “essential” drugs and medical supplies purchased by the federal government be manufactured in...
FDA Approves Belantamab Mafodotin-blmf for Relapsed/Refractory Multiple Myeloma
Belantamab mafodotin-blmf, an anti–B-cell maturation antigen (BCMA) antibody-drug conjugate therapy, received accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma...
Tafasitamab-cxix Receives Accelerated Approval for Relapsed/Refractory DLBCL
The FDA granted accelerated approval to tafasitamab-cxix in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma...
White House Introduces Executive Orders Addressing Drug Prices
President Donald Trump has announced four new executive orders that are aimed at lowering drug prices. The orders instruct the Department of Health and...
First CAR T-Cell Treatment Approved for Mantle Cell Lymphoma
The FDA granted accelerated approval to brexucabtagene autoleucel (formerly KTE-X19), a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with...
FDA Approves Decitabine and Cedazuridine Combination for MDS
The FDA approved an oral combination of decitabine and cedazuridine for adults with myelodysplastic syndromes (MDS), including:
those with previously treated and untreated, de...
FDA Approves New HIV Treatment for Patients With Restricted Options
The FDA has approved fostemsavir for adult patients with HIV who have tried multiple medications and whose HIV infection cannot be successfully treated with...
Indication Expanded for Gemtuzumab Ozogamicin
The FDA has extended the indication of gemtuzumab ozogamicin to include pediatric patients aged 1 month or older with newly diagnosed CD33-positive acute myeloid...
Oral Selinexor Approved for Relapsed/Refractory DLBCL
The FDA has granted accelerated approval to selinexor for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL...
Current Issue
October 2020 Volume 6, Issue 12
This issue examines racism in the U.S. health care system, discusses the FDA's newly loosened blood donation restrictions, and more.