Latest & Greatest

Latest & Greatest

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

CMS Proposes Public Reporting of Medical Facility Inspections

A new rule from CMS proposes increasing transparency of the inspection process of medical facilities by requiring that private health-care accreditors (the largest of...

PubMed to Disclose Funding Information of Studies Up Front

In March, the National Library of Medicine (NLM) implemented a series of changes to how conflict-of-interest (COI) information is displayed in PubMed-indexed abstracts. COI...

CTL019 Being Reviewed for DLBCL and ALL

The U.S. Food and Drug Administration (FDA) granted breakthrough-therapy designation for CTL019, a chimeric antigen receptor T-cell therapy, for adult patients with relapsed/refractory diffuse large...

FDA Lifts REMS Requirement for ESAs for Anemia

The U.S. Food and Drug Administration (FDA) has lifted its risk evaluation and mitigation strategy (REMS) certification requirement for erythropoiesis-stimulating agents (ESAs), specifically epoetin...

FDA Cautions Breast Augmentation May Be Linked to ALCL

The FDA is looking into 359 reports linking silicone and saline breast implants with development of anaplastic large cell lymphoma (ALCL), a rare type...

Manufacturers of KTE-C19 Report Patient Death

The manufacturer of the investigational chimeric antigen receptor (CAR) T-cell therapy KTE-C19 reported that one patient enrolled in the safety expansion phase of the...

FDA Grants Marketing Authorization for Genomic Sequencing Kit for PV

The U.S. Food and Drug Administration (FDA) granted marketing authorization to ipsogen JAK2 RGQ PCR Kit for the detection of JAK2 mutations. This is...

Ibrutinib Granted Supplemental New Drug Application for Chronic GVHD

The U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application of ibrutinib for patients with chronic graft-versus-host disease (cGVHD) who have...

FDA Approves Midostaurin Combination for AML and Systemic Mastocytosis

The U.S. Food and Drug Administration (FDA) approved midostaurin in combination with 7+3 induction and consolidation chemotherapy with daunorubicin and cytarabine for the treatment...

FDA Places Partial Clinical Hold on Selinexor for Multiple Myeloma

The FDA placed clinical trials of selinexor on a partial hold, halting enrollment of new patients in the studies but allowing those who have...
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Current Issue

July 2017, Volume 3, Issue 8

This issue features an interview with the FDA's Richard Pazdur, highlights from the 2017 ASCO Annual Meeting, a debate about minimal residual disease in myeloma, and more.