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TXT FDA Clears Xtant Medical Xspan Laminoplasty Fixation [119 Words] [ Price : $8.95]
FDA clears an Xtant Medical Holdings 510(k) for the Xspan Laminoplasty Fixation System and its use in the lower cervical and upper thoracic spine (C3-T3).
03/30/2016
 
 
TXT Republicans Prod Califf on Heparin Findings [424 Words] [ Price : $8.95]
House Energy and Commerce Committee Republican leaders ask FDA for information and documents relating to the ongoing investigation into contaminated heparin in 2007-2008.
03/30/2016
 
 
TXT Many GDUFA Goals Met, Exceeded, FDA Says [199 Words] [ Price : $8.95]
FDA says it is meeting or exceeding many of its performance goals from the GDUFA 3 commitment letter.
03/30/2016
 
 
TXT SEC Says Aveo Misled Tivozanib Investors [150 Words] [ Price : $8.95]
Aveo Pharmaceuticals says it will pay $4 million to settle investor fraud charges involving its kidney cancer drug tivozanib.
03/30/2016
 
 
TXT FDA Panel Backs Acadia Parkinsonís Psychosis Drug [112 Words] [ Price : $8.95]
FDAís Psychopharmacologic Drugs Advisory Committee votes 12 to 2 to support approval of an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) and its use in treating psychosis associated with Parkinsonís Disease.
03/30/2016
 
 
TXT Zika Blood Donation Screen Available: FDA [5267 Words] [ Price : $8.95]
FDA says a Roche investigational test to screen blood donations for Zika virus is available for use under an IND.
03/30/2016
 
 
TXT Novartis Violated Integrity Agreement: Justice Dept. [193 Words] [ Price : $8.95]
The Justice Department says that Novartis has violated a 2010 Corporate Integrity Agreement and should face tougher penalties for a kickback scheme involving phony doctor educational programs on its cardiovascular drugs.
03/30/2016
 
 
TXT Mifeprex Expanded Label Approved by FDA [228 Words] [ Price : $8.95]
FDA approves a supplemental NDA for Danco Laboratoriesí abortifacient Mifeprex (mifepristone) to relax label requirements for administering the drug.
03/30/2016
 
 
TXT Animal Drug Regs Reflect 2015 Actions [79 Words] [ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug to reflect application-related actions for NADAs and ANADAs during 11/2015 and 12/2015.
03/30/2016
 
 
TXT Jazz NDA for Liver Condition After Stem Cell Transplant [166 Words] [ Price : $8.95]
FDA approves a Jazz Pharmaceuticals NDA for Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after receiving a hematopoietic stem cell transplantation.
03/30/2016
 
 
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