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Innovative Neulasta® Onpro® Kit is Designed to Provide the Right Dose for Patients at the Right Time THOUSAND OAKS, Calif., Feb. 27, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that...
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...
NewsAmgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta (peg...
European regulators have accepted a resubmission of Gedeon Richter’s biosimilar to Amgen’s Neulasta.
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....
The US FDA has approved Mylan and Bioconâs Fulphila, the first biosimilar version of Amgenâs Neulasta to receive regulatory authorisation.
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...
The development of radiation countermeasures for acute radiation syndrome (ARS) has been underway for the past six decades, leading to the identification of multiple classes of radiation countermeasur...
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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