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Tag: fda
FDA grants orphan drug status to NBI-77860 for treatment of congenital adrenal hyperplasia
2015-01-18 02:02:31| Biotech - Topix.net
Neurocrine Biosciences, Inc. announced today that NBI-77860, a proprietary corticotropin releasing factor 1 receptor antagonist, has been granted orphan drug status by the United States Food and Drug Administration for the treatment of congenital adrenal hyperplasia a disease that affects approximately 20,000-30,000 people in the United States. "We are very pleased that the FDA has granted NBI-77860 orphan status to treat congenital adrenal hyperplasia, a devastating disease that is a significant challenge for both clinicians and patients," said Malcolm Lloyd-Smith, Chief Regulatory Officer of Neurocrine Biosciences.
Tags: status
treatment
drug
grants
Baytril FDA approved for control of E. coli in swine
2015-01-15 06:00:00| National Hog Farmer
The U.S. Food and Drug Administration recently approved changes in the label claims for Baytril 100 (enrofloxacin). The drug may now be used intramuscularly or subcutaneously for the control of colibacillosis in groups of swine where E. coli has been diagnosed. This is in addition to the previous indication for treatment and control of swine respiratory disease. [Source: FDA and Bayer] read more
Tags: in
control
approved
coli
FDA to implement food safety rules
2015-01-14 01:00:00| Food Processing Technology
The US Food and Drug Administration is set to implement new food safety legislation across the country.
Tags: food
rules
safety
implement
BIO urges FDA to release guidance on biosimilars.
2015-01-12 14:31:03| Industrial Newsroom - All News for Today
Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. BIO calls on the FDA to release final guidance on processes and scientific criteria for approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining biosimilar to be interchangeable with its reference biological.
Tags: release
bio
guidance
fda
The BD(TM) Intelliport Medication Management System Receives Clearance from the Food and Drug Administration (FDA)
2015-01-12 11:31:08| Industrial Newsroom - All News for Today
First-of-its-kind medication management solution for manual IV bolus injections expected to be available commercially in spring 2015 FRANKLIN LAKES, N.J. BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that the U.S. Food and...
Tags: system
management
food
administration
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