White Blood Cell Disorders

FDA Approves Biosimilar Udenyca for Patients Receiving Myelosuppressive Chemotherapy

By November 05, 2018

Udenyca will be supplied as 6mg/0.6mL preservative-free solution in prefilled syringes for subcutaneous injection.

Granix Indication Expanded to Include Pediatric Patients

By August 07, 2018

The pediatric approval was supported by evidence from studies in adults with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with Granix for chemotherapy-induced neutropenia.

Biosimilar Nivestym Gets FDA Approval

By July 23, 2018

The approval was based on data demonstrating that the biosimilar product and the reference product are highly similar, and that there are no clinically meaningful differences between the 2 agents.

First Biosimilar Pegfilgrastim Gets FDA Approval

By June 05, 2018

Fulphila will be available as a 6mg/0.6mL single-dose prefilled syringe for subcutaneous (SC) injection.

FDA Approves Third Countermeasure for Acute Radiation Syndrome

By March 30, 2018

The FDA approval was supported by efficacy studies in animals as they could not be ethically conducted in humans.

Antithyroid Drug Induces Rare, Dangerous Side Effect

By May 11, 2017

"Periodic screening and monitoring of CBC while on treatment is crucial to monitor development of neutropenia which can be totally asymptomatic," the authors concluded.

Novel Budesonide Prep May Treat Rare GI Disorder

March 28, 2017

A trial involving 93 eosinophilic esophagitis patients aged 11 to 40 years with dysphagia were randomly allocated to receive either budesonide oral suspension or placebo twice daily.

FDA to Review Potential Neulasta Biosimilar

February 16, 2017

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim).

Neulasta Biosimilar to Be Reviewed by FDA

By October 07, 2016

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 to Neulasta.

Hypertension Drug Causes Rare, but Serious Side Effect

By June 29, 2016

Increased awareness among clinicians about this rare but potentially lethal adverse effect is warranted.

Zarxio Labeling Updated With New Warning

By March 08, 2016

The FDA has approved a supplemental Biologics License Application (sBLA) for Zarxio (filgrastim-sndz; Sandoz) to update the Warnings and Precautions section of the drug label.

Neupogen Gains Acute Radiation Syndrome Indication

By April 06, 2015

The FDA has approved a Supplemental Biologics License Application (sBLA) for Neupogen (filgrastim; Amgen) to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hemopoietic syndrome of acute radiation syndrome).

First Biosimilar Product Approved by the FDA

By March 06, 2015

The Food and Drug Administration (FDA) has approved the first biosimilar product, Zarxio (filgrastim-sndz; Sandoz).

Neulasta Delivery Kit Provides New Option for Patients

By March 03, 2015

Amgen announced the launch of Neulasta (pegfilgrastim) Delivery Kit that allows the healthcare provider to initiate Neulasta on the same day as chemotherapy along with a full dose of Neulasta the following day.

New Granix Syringes Approved for Self-Administration

By February 02, 2015

Teva Oncology announced the launch of a new single-use pre-filled syringe for self-administration for Granix (tbo-filgrastim).

Non-Cancer Drugs Commonly Linked to Agranulocytosis

August 20, 2014

Medications that are commonly linked to agranulocytosis development include clozapine, an atypical antipsychotic used in the treatment of schizophrenia, trimethoprim-sulfamethoxazole, an antibiotic, and methimazole, an agent for treating hyperthyroidism.

First Drug Approved for Multicentric Castleman's Disease

April 24, 2014

Janssen Biotech announced that the FDA has approved Sylvant (siltuximab) for the treatment of patients with multicentric Castleman's disease (MCD) who are HIV negative and HHV-8 negative.

Lowering WBC Criteria Lowers Negative Appendectomy Rate

January 09, 2014

Reducing the threshold of leukocytosis as a criterion for appendicitis to 8,000-9,000 white blood cells (WBCs) per µL reduces the rates of negative appendectomy.

White Blood Cell Count Predicts Infarct Size in STEMI

December 19, 2013

For patients with anterior wall ST-segment elevated myocardial infarction (STEMI), elevated white blood cell count (WBCc) on presentation is associated with increased infarct size.

Siltuximab BLA Submitted for Rare Blood Disorder

September 03, 2013

Janssen R&D submitted a Biologic License Application (BLA) to the FDA for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

Moxifloxacin Monotherapy Equivalent to Antibiotic Combo

January 30, 2013

Oral monotherapy with moxifloxacin is as efficacious and safe as combination therapy with ciprofloxacin plus amoxicillin/clavulanic acid for treatment of fever in adult patients with cancer and neutropenia who are at low risk of complications.

Phase 3 Results Announced for Neulasta in Colorectal Cancer

January 28, 2013

Amgen announced the results from a Phase 3 study, Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES) which evaluated Neulasta (pegfilgrastim) for the first-line treatment of locally-advanced or metastatic colorectal cancer.

New Guidelines Issued for Pediatric Fever and Neutropenia

September 19, 2012

New evidence-based guidelines have been compiled on the management of fever and and neutropenia (FN) in children with cancer and/or who are undergoing hematopoietic stem-cell transplantation

Tbo-filgrastim Approved for Chemotherapy-Induced Neutropenia

August 30, 2012

Teva announced that the FDA has approved Tbo-filgrastim (XM02 filgrastim injection solution), the first granulocyte colony-stimulating factor (G-CSF) to be approved in the United States in more than 10 years.