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Pernix Therapeutics Receives FDA Approvals
2013-02-28 10:00:00| foodingredientsonline News Articles
Pernix Therapeutics Holdings, Inc. (“Pernix” or the “Company”), a specialty pharmaceutical company, recently announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for VITUZ® Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate)
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Stivarga (regorafenib) Tablets Approved By U.S. FDA For Treatment Of...
2013-02-27 14:35:23| Chemicals - Topix.net
Bayer HealthCare and Onyx Pharmaceuticals, Inc. have announced that the U.S. Food and Drug Administration approved Bayer's Stivarga tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate.1 Stivarga was approved by the FDA ... (more)
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How To Survive An FDA Audit
2013-02-27 10:08:14| dairynetwork Home Page
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records and conducting audits more frequently – up from .06 to .09 per year, according to Bloomberg News. By Paul Dupont, Ropack
FDA halts trials of Amgen drug in children, cites death
2013-02-26 19:55:29| Biotech - Topix.net
The Food and Drug Administration said on Tuesday it has stopped all pediatric clinical trials of Amgen Inc's Sensipar after the death of a 14-year-old patient taking part in a study of the drug.
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FDA Expands Approval of Bayer Cancer Drug
2013-02-26 16:40:57| Biotech - Topix.net
The Food and Drug Administration on Monday expanded approval of a Bayer cancer pill to treat tumors of the intestinal tract that don't respond to other treatments.
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approval
cancer
expands
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