Online Exclusives

Online Exclusives

FDA Committee Votes to Withdraw Two Accelerated Approvals of Cancer Treatments

The U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) recommended withdrawing two of six accelerated approvals of cancer treatments that it...

Pipette Tip Shortage Hinders Scientific Work Worldwide

An ongoing pipette tip shortage caused by the COVID-19 pandemic, blackouts in Texas, and a manufacturing plant fire is hindering scientific work around the...

Will the FDA Crack Down on Clinical Trial Reporting Noncompliance?

The U.S. Food and Drug Administration (FDA) has issued its first notice of noncompliance to Acceleron Pharma for failing to submit clinical trial results...

FDA Committee Meets to Reconsider Accelerated Approvals of Cancer Drugs

On April 27, the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee began its first meeting in a decade to reconsider accelerated...

Are Survivors of Childhood Lymphomas At Increased Risk of Cognitive Impairment?

Researchers from the Yale Cancer Center report that the systemic therapies received by survivors of childhood cancers may impact their long-term cognitive outcomes, with...

Beam Therapeutics Develops Inlaid Base Editing Technique for SCD

Beam Therapeutics is testing a new form of CRISPR-based technology called inlaid base editing to modify cells from patients with sickle cell disease (SCD). Base...

LentiGlobin Not Linked to Cancer, Scientists Say

On February 24, the U.S. Food and Drug Administration (FDA) placed a clinical hold on all LentiGlobin gene therapy trials following an announcement that two participants with...

FDA to Reevaluate Six Accelerated Approvals of Cancer Treatments

The FDA held a public meeting of its Oncologic Drugs Advisory Committee in late April to reevaluate six treatments that were previously granted accelerated...

FDA Deputy Commissioner and CIO Amy Abernethy Resigns

Amy Abernethy, MD, PhD, has announced her resignation from her roles as principal deputy commissioner and acting chief information officer at the FDA. Two years...

Idecabtagene Vicleucel Approved for Relapsed or Refractory Multiple Myeloma

The FDA has approved idecabtagene vicleucel (ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy for the treatment of...
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Current Issue

May 2021 Volume 7 Issue 6

This issue provides an update on gene therapies in hematology, demystifies RNA sequencing, and more.

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