Online Exclusives

Online Exclusives

FDA Places Clinical Hold on Studies of Allogeneic CAR T-Cell Therapy

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on two phase I trials of gene-edited allogeneic chimeric antigen receptor (CAR)...

Hurricane Harvey Flooding Causes High Levels of Carcinogenic Substance

Flooding from Hurricane Harvey damaged an oil refinery in Houston, Texas, releasing dangerous amounts of the carcinogen benzene into the air. The compound is...

Senate Appropriations Committee Approves New Funding Bill for NIH and Opioid Crisis

On September 7, the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee approved the 2018 Labor, Health and Human Services, Education, and...

FDA Places Holds on Clinical Trials of Anti-PD-1 Agent

The U.S. Food and Drug Administration (FDA) placed partial clinical holds on five trials and a full clinical hold on one trial of the...

FDA Approves Gemtuzumab Ozogamicin for AML

The U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for two indications: adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) and...

FDA’s CDER Reiterates Safety Risks Associated With Pembrolizumab in Myeloma Trials

The U.S. Food and Drug Administration (FDA) released a statement alerting clinicians and researchers to the risks associated with the investigational use of the...

FDA Promises a Crackdown on Unlicensed Stem Cell Clinics

On August 28, the U.S. Food and Drug Administration (FDA) announced it is taking “decisive actions” to prevent the use of unproven, potentially harmful...

NIH All of Us Research Program Expands to Include More Medical Centers

The National Institute of Health (NIH) announced that  the All of Us Research Program – a precision medicine research initiative with the goal of...

FDA Approves First CAR T-Cell Therapy for Young Patients With ALL

The U.S. Food and Drug Administration (FDA) approved the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel for the treatment of pediatric and young adult...

SY-1425 Granted Orphan-Drug Designation for Treatment of AML and MDS

The U.S. Food and Drug Administration granted orphan-drug designation to SY-1425 (tamibarotene) for the treatment of patients with acute myeloid leukemia (AML) or myelodysplastic...
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Current Issue

September 2017, Volume 3, Issue 11

This issue features a look at efforts to include individuals with intellectual and developmental disabilities in clinical research, our new "How I Treat In Brief" section, and more.