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Neutropenia Associated with Chemotherapy News
Coherus Announces FDA Approval of Udenyca Onbody™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
Innovative design enables five-minute pegfilgrastim delivery time Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...
FDA Approves Rolvedon (eflapegrastim-xnst) Injection to Decrease the Incidence of Chemotherapy-Induced Neutropenia
First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years Rolvedon™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and proven safety and e...
FDA Approves Stimufend (pegfilgrastim-fpgk), a Biosimilar to Neulasta
September 6, 2022 – Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced...
FDA Approves Releuko (filgrastim-ayow), a Biosimilar to Neupogen
PISCATAWAY, N.J.--(BUSINESS WIRE)-- March 2, 2022 Kashiv Biosciences, LLC (“Kashiv”) today announced the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for...
FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta
NEW YORK--(BUSINESS WIRE)-- June 11, 2020 – Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a...
FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (...
FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta
REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca...
FDA Approves Nivestym (filgrastim-aafi), a Biosimilar to Neupogen
July 20, 2018 - Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen1...
FDA Approves Fulphila (pegfilgrastim-jmdb), the First Biosimilar to Neulasta
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ – Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food...
FDA Approves First Biosimilar Product Zarxio (filgrastim-sndz)
March 6, 2015 – The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. Biological products are generally derived...
FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration
JERUSALEM, December 23, 2014--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Granix (tbo-filgrastim)...
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
August 29, 2012 – The U.S. Food and Drug Administration today approved Sicor Biotech’s tbo-filgrastim to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia, ...
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