Latest & Greatest

Latest & Greatest

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

Bluebird Bio Wins European Approval for Beta Thalassemia Gene Therapy

Bluebird Bio’s one-time gene therapy, Zynteglo, has been cleared by E.U. regulators for the treatment of beta thalassemia in patients aged 12 and older....

Opioid Manufacturer Insys Therapeutics Files for Bankruptcy

Insys Therapeutics filed for Chapter 11 bankruptcy protection on June 10, just days after reaching a $225 million settlement with the U.S. Department of...

FDA Launches Call Center for Compassionate-Use Requests

The FDA has launched a call center to field doctors’ requests for access to experimental cancer drugs for individual patients who have run out...

Polatuzumab Vedotin-piiq Receives FDA Approval for DLBCL

The FDA has approved the CD79b-directed antibody drug conjugate polatuzumab vedotin-piiq, in combination with bendamustine and rituximab (BR), to treat adults with relapsed or...

Mixed Opinions on Quizartinib From the FDA and Japanese Regulators

After the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee decided against recommending approval of quizartinib for patients with relapsed/refractory FLT3-ITD acute...

FDA Approves First Anticoagulant for Pediatric Patients

The FDA approved dalteparin sodium, administered as a subcutaneous injection, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients (≥1 month). Dalteparin...

Trump Administration Ends Fetal Tissue Research at NIH

In June, the Department of Health and Human Services (HHS) announced a new policy curtailing government-funded research that uses fetal tissue donated after elective...

FDA Recalls Three Hematology Analyzers

The FDA issued a Class I recall of three hematology analyzers – Beckman Coulter DxH 800, DxH 600, and DxH 900 – after reports...

FDA to Close Its Controversial Medical Device Reporting Program

In what is being called a victory for patients and consumers, the U.S. Food and Drug Administration (FDA) said that it is ending its...

FDA Expands Ivosidenib’s Indication to Newly Diagnosed AML

On May 2, 2019, The U.S. Food and Drug Administration (FDA) approved an expanded indication for the IDH1 inhibitor ivosidenib to include the treatment...
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Current Issue

October 2019, Volume 5, Issue 12

This issue highlights the unintended consequences of fighting the nation’s opioid epidemic, considers the optimal frontline regimen for myeloma, and more.