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PBOA Praises Action On FDA Reauthorization contractpharma
April 18, 2017
Congress releases a Discussion Draft of the FDA Reauthorization Act for GDUFA
FDA Announces Nationwide Voluntary Recall of Hyland’s Teething Tablets americanpharmaceuticalreview
April 17, 2017
FDA has announced a nationwide voluntary recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets from Standard Homeopathic Company.
FDA Determines Erythropoiesis-Stimulating Agents Risk Evaluation and Mitigation Strategy No Longer N americanpharmaceuticalreview
April 17, 2017
In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS), In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS).
U.S. FDA Issues Complete Response Letter for Baricitinib lilly
April 17, 2017
Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA)...
FDA warning slams St Jude's "inadequate response" to device failures pharmafile
April 14, 2017
St Jude Medical has been hit with a warning letter from the FDA over the medical device manufacturer’s failure to address issues with its implantable defibrillators and at-home monitoring equipment.
US FDA approves Neurocrine’s Ingrezza capsules to treat tardive dyskinesia pharmaceutical-technology
April 14, 2017
The US Food and Drug Administration (FDA) has approved Neurocrine Biosciences’ Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia (TD).
Analysis of New Drug Approval of FDA in 2017 Q1: Drugs Approved in the 3 Months were Nearly Half of en-cphi.cn
April 14, 2017
2017 is a year worth expecting, with the innovative drug development nonstop.
FDA approves first drug to treat tardive dyskinesia europeanpharmaceuticalreview
April 14, 2017
The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.
FDA Approves Ingrezza drugs.com
April 12, 2017
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD).
FDA Grants Nanobiosym Diagnostics Emergency Use Authorization for Gene-RADAR® Zika Virus Test americanpharmaceuticalreview
April 12, 2017
Nanobiosym Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Gene-RADAR® Zika Virus Test.

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