Online Exclusives

Online Exclusives

FDA Places Clinical Hold on LentiGlobin Gene Therapy Trials

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on all LentiGlobin gene therapy trials following an announcement that two participants...

Novartis and the Gates Foundation Collaborate on Off-the-Shelf Gene Therapy for Sickle Cell Disease

Novartis and the Bill and Melinda Gates Foundation are collaborating on a one-step, one-time gene therapy for patients with sickle cell disease (SCD). The...

‘All of Us’ Technology Platform Aims to Democratize Research

All of Us, a $1.5 billion National Institutes of Health (NIH) initiative to collect DNA and health data on one million Americans from diverse...

FDA Accepts IND Application for PBCAR19B

The FDA cleared Precision BioSciences’ Investigational New Drug (IND) application for its chimeric antigen receptor (CAR) T-cell therapy PBCAR19B. The company will initiate a...

IND Application Cleared for VOR33 in CD33+ Acute Myeloid Leukemia

The FDA cleared Vor Biopharma’s IND application for its hematopoietic cell therapy VOR33. This decision allows the company to initiate a phase I/IIa clinical...

VLX-1005 Receives Orphan Drug Designation

The FDA granted orphan drug designation to VLX-1005 as thrombosis prophylaxis in patients with heparin-induced thrombocytopenia (HIT). According to its manufacturer, Veralox Therapeutics, preclinical data...

FDA Issues Guidance for Measuring Viscoelasticity Amid COVID-19 Pandemic

The FDA has issued immediate guidance for expanding the availability and capability of coagulation systems for measuring whole blood viscoelastic properties to assess hemostasis....

FDA Plans For “Nimble” Response to Coronavirus Variants

U.S. Food and Drug Administration (FDA) officials say the agency is developing plans for evaluating changes to the approved COVID-19 vaccines to make them...

Are Rare Cases of Immune Thrombocytopenia Linked to the COVID Vaccine?

A small number of patients have developed immune thrombocytopenia (ITP) after receiving the Pfizer/BioNTech and Moderna coronavirus vaccines. Whether the onset of the condition...

Johns Hopkins Researchers Address COVID-19 Supply Chain Issues

Researchers at the Johns Hopkins Bloomberg School of Public Health have published a report assessing the COVID-19 pandemic’s impact on the U.S. pharmaceutical supply...
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Current Issue

April 2021 Volume 7 Issue 5

This issue examines long-haul COVID-19, central nervous system relapse in non-Hodgkin lymphoma, and more.

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