FDA Approves Autoinjector Presentation of Pegfilgrastim Biosimilar Udenyca
The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care.
Diagnosis & Disease Information
Avapritinib Gets Priority Review for Indolent Systemic Mastocytosis
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
Rolvedon Now Available for Chemotherapy-Induced Neutropenia
Rolvedon is a long-acting granulocyte colony-stimulating factor.
Stimufend, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on a review of a comprehensive data package and a totality of evidence demonstrating a high degree of similarity of Stimufend to the reference product.
Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
Manufacturing Deficiencies Delay Decision on Eflapegrastim
Eflapegrastim is a novel, long-acting G-CSF comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment.
Neulasta Ad Claims Misleading, May Undermine Biosimilar Use, Says FDA
The ad claims that there is a higher risk of febrile neutropenia when pegfilgrastim is administered via prefilled syringe vs Neulasta Onpro on-body injector.
Ayvakit Approved for Advanced Systemic Mastocytosis
The approval was based on data from 2 multicenter, single-arm, open-label clinical trials that evaluated Ayvakit in 53 patients with advanced systemic mastocytosis.
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