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Amgen’s Neulasta is set to face its first competition in the US after the FDA approved Mylan’s biosimilar version of the blockbuster cancer infection biologic. Neulasta brought in $4.5 billion fo...
Udenyca will be the second biosimilar in the U.S. to challenge Amgen's Neulasta when it hits markets in early January.
The Mundipharma network of independent associated companies says European regulators have approved use of Pelmeg, a biosimilar of Amgen’s white blood cell booster Neulasta.
Coherus BioSciences' Udenyca, or pegfilgrastim-cbqv, a biosimilar version of Amgen's Neulasta, received approval from the Eu -More-
Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.
The FDA has granted approval to Mylan and Biocon’s Fulphila, the first biosimilar version of Amgen’s Neulasta (pegfilgrastim) to be approved in the US. The pair’s second authorised biosimilar in...
(Reuters) - The U.S. Food And Drug Administration on Monday approved a drug from Mylan NV as the first biosimilar to Amgen's drug Neulasta to help reduce the risk of infection during cancer treatment....
With the June approval of Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Amgen’s Neulasta (pegfilgrastim), the company is facing a potential revenue problem as the Mylan drug is expected t...
These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta.Neulasta (pegfilgrastim) injection, for subcutaneous us...
These highlights do not include all the information needed to use Neulasta safely and effectively. See full prescribing information for Neulasta. Neulasta (pegfilgrastim) injection, for subcutaneous u...
A nonhuman primate model of acute, partial-body, high-dose irradiation with minimal (2.5%) bone-marrow sparing was used to assess endogenous gastrointestinal and hematopoietic recovery and the ability...
Understanding the physiopathology underlying the Acute Radiation Syndrome (ARS) and the mechanism of action of drugs known to ameliorate ARS is expected to help identify novel countermeasure candidate...
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-a...
This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy...
This study seeks to determine if giving a a 12 week course of Neulasta to people with recent onset type 1 diabetes is (1) safe and (2) can preserve insulin production.
This is a Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and Neulasta (Pegfilgrastim) in Stage II/III Breast Cancer Patients Receiving Neoadjuvan...
Neulasta® (pegfilgrastim) is approved for once-per-cycle dosing to decrease the incidence of infection (as manifested by febrile neutropenia)in certain cancer patients who are receiving chemotherapy.
Established in 2005 in New York as Lexington Pharmaceuticals, TRACON remains a privately held company. In April 2005, the company named Bert Liang as President and Chief Executive Officer and moved to...
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