Latest & Greatest

Latest & Greatest

Recent developments in the field of hematology/oncology, including drug approvals, policy updates, and clinical trial results

FDA Grants Orphan-Drug Designation for Hemophilia Gene Therapy

The FDA granted orphan-drug designation to the adeno-associated virus stereotype vector SHP654 (also known as BAX 888), an investigational factor VIII (FVIII) gene therapy...

NIH Announces Partnership for Accelerating Cancer Therapies

The National Institutes of Health (NIH) joined with 11 biopharmaceutical companies to launch the Partnership for Accelerating Cancer Therapies (PACT), a five-year, public-private research...

FDA Grants Orphan-Drug Designation to PCM-075 for AML

The FDA granted orphan-drug designation to PCM-075 for the treatment of acute myeloid leukemia (AML). PCM-075 is an oral, highly selective adenosine triphosphate competitive...

Several Anti-Cancer Drugs On Updated FDA “Watch List”

The FDA released a watch list that includes 19 drugs or drug classes, seven of which are cancer therapies, which may have serious risks...

First Test to Screen for Zika Virus in Blood Donations Receives Approval

The FDA approved the cobas Zika test, the first test for screening the nation’s blood supply and organ donations for the Zika virus. The...

Compassionate-Use Program Is More Accessible

The FDA is easing restrictions on its compassionate-use program, also known as expanded access, to help streamline the process through which seriously ill patients...

FDA Grants Breakthrough-Therapy Designation to Brentuximab Vedotin for Frontline Treatment of HL

The FDA granted breakthrough-therapy designation to brentuximab vedotin (BV) for frontline treatment of classical Hodgkin lymphoma (cHL). The decision was based on results from the...

Maryland Enacts First-of-Its-Kind 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...

User-Friendly Adverse Events Reporting System Now Available

The U.S. Food and Drug Administration (FDA) launched the FDA Adverse Event Reporting System (FAERS): Public Dashboard, a user-friendly search tool that improves access...

FDA Grants Breakthrough-Therapy Designation to Gene Therapy for Hemophilia A

The FDA granted breakthrough-therapy designation to valoctocogene roxaparvovec (formerly BMN 270), an adeno-associated virus 5 FVIII vector designed to restore FVIII plasma concentrations in...
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Current Issue

December 2017, Volume 3, Issue 14

This issue features physicians' insights on gun control, the use of cannabis for symptom relief, and more.