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Tag: fda approval
Novartis Wins FDA Approval For Zarxio, First Biosimilar Drug In The US
2015-03-06 22:24:27| Biotech - Topix.net
U.S. regulators on Friday gave a green light to sales of the country's first copied version of a biotechnology drug, or "biosimilar," with approval of Novartis' white blood cell-boosting Zarxio. The drug contains the same active ingredient as Neupogen, or filgrastim, which logged 2014 worldwide sales of $1.2 billion for manufacturer Amgen.
Archroma Receives FDA Food Contact Approval for Cartaguard KST
2015-03-02 06:00:00| Coatings World Breaking News
Tags: contact
food
approval
receives
Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC
2015-02-14 13:04:00| Biotech - Topix.net
Eisai Inc. announced today that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer . LENVIMA was approved following a priority review by the FDA, which is designated for drugs the FDA believes have the potential to provide a significant improvement in the treatment of a serious condition.
Tags: treatment
approval
announces
fda
Pfizer Receives U.S. FDA Accelerated Approval Of IBRANCE (palbociclib)
2015-02-04 06:14:13| drugdiscoveryonline Home Page
Pfizer Inc. recently announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of IBRANCE (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease
Tags: approval
receives
accelerated
fda
NxStage nabs first-ever FDA approval for overnight home hemodialysis
2014-12-29 22:34:30| Biotech - Topix.net
The Lawrence medical device company that virtually invented the market for home-based hemodialysis treatment, NxStage Medical, last week earned the first approval to be used overnight while the patient is at home sleeping.
Tags: home
approval
overnight
fda
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