Online Exclusives

Online Exclusives

EMA Transitions May Affect Drug Approvals and Public Health Safety

Because the headquarters of the European Medicines Agency (EMA) must be located in a country within the European Union (E.U.), the agency will need...

FDA Eases Restrictions on Its Compassionate-Use Program

The U.S. Food and Drug Administration (FDA) is easing restrictions on its compassionate-use program, also known as expanded access, which gives seriously ill patients...

FDA Approves First Zika Screening Test

The U.S. Food and Drug Administration (FDA) approved the cobas Zika test, the first test for screening the nation’s blood supply and organ donations...

European Commission Approves Obinutuzumab Combination Treatment for FL

The European Commission approved obinutuzumab in combination with chemotherapy as firstline treatment for patients with previously untreated, advanced follicular lymphoma (FL), followed by obinutuzumab...

Maryland Enacts First Price-Gouging Law for Pharmaceutical Companies

By denying an injunction filed by a generic-drug industry trade group, a U.S. District Court allowed Maryland to implement the first law penalizing drug...

FDA Works to Mitigate Drug Shortages After Hurricane in Puerto Rico

After Hurricane Maria wreaked havoc in Puerto Rico, leaving the entire island without power for an extended period, the U.S. Food and Drug Administration...

GBT440 Gets Rare Pediatric Disease Designation for SCD

The U.S. Food and Drug Administration granted rare pediatric disease designation to GBT440, a once-daily, oral, small-molecule, “anti-sickling” hemoglobin modifier, for the treatment of...

FDA Places Holds on Two Clinical Trials for Atezolizumab

The U.S. Food and Drug Administration (FDA) placed partial holds on two clinical trials evaluating the anti–PD-1 agent atezolizumab in patients with relapsed or...

European Commission Approves Midostaurin for AML and Systemic Mastocytosis

The European Commission approved midostaurin (an oral, multitargeted protein kinase inhibitor) for two indications: in combination with standard daunorubicin and standard cytarabine induction therapy...

Evaluating CD30-Targeted CAR T-Cell Therapy in Patients With HL or ALCL

Author’s Perspective Study co-author Barbara Savoldo, MD, PhD: “Our study demonstrates the tolerability, safety, and potential efficacy of CD30-directed chimeric antigen receptor (CAR) T-cell (CD30...
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Current Issue

October 2017, Volume 3, Issue 12

This issue features a look at hospital ranking systems, the risks and benefits of opioids for pain management, and more.