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TXT Taro Recalls 1 Lot of Contaminated Lamotrigine [127 Words] [ Price : $8.95]
Taro Pharmaceuticals recalls one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a small amount of enalapril maleate.
01/13/2020
 
 
TXT Aidoc AI Stroke Detection Module Cleared [154 Words] [ Price : $8.95]
FDA clears an Aidoc 510(k) for its artificial intelligence component for flagging large-vessel occlusion in head computed tomography angiography scans.
01/13/2020
 
 
TXT Galemed Recalls Infant Breathing Manifold [255 Words] [ Price : $8.95]
Galemed recalls (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure.
01/13/2020
 
 
TXT FDA Accepts Re-filed NDA for Acromegaly Drug [300 Words] [ Price : $8.95]
FDA accepts for review a Chiasma NDA resubmission for Mycapssa (octreotide) capsules for the maintenance treatment of adults with acromegaly.
01/13/2020
 
 
TXT sNDA for Lynparza Accepted for Review [247 Words] [ Price : $8.95]
FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of certain women with advanced ovarian cancer.
01/13/2020
 
 
TXT Meeting on Asbestos in Talc and Cosmetic Products [103 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.”
01/10/2020
 
 
TXT Meissa Gains Fast Track for RSV Infection Vaccine [122 Words] [ Price : $8.95]
FDA grants Meissa Vaccines a fast track designation for MV-012-968, a vaccine for protection against respiratory syncytial virus infection.
01/10/2020
 
 
TXT Reflow Medical ‘Breakthrough’ for Stent System [111 Words] [ Price : $8.95]
FDA grants Reflow Medical a breakthrough device designation for the Temporary Spur Stent System, a novel retrievable stent technology intended for treating below-the-knee peripheral artery disease.
01/10/2020
 
 
TXT MicroVention Flow Diverter OK’d for Brain Aneurysm [114 Words] [ Price : $8.95]
FDA approves a MicroVention PMA for the FRED (Flow Re-Direction Endoluminal Device) device for treating brain aneurysms.
01/10/2020
 
 
TXT Petition Seeks to Stop FDA Enforcement on PGx Info [307 Words] [ Price : $8.95]
The Coalition to Preserve Access to Pharmacogenomics Information petitions FDA urging it to stop enforcement actions against genetic tests that claim to predict a patient’s response to specific medications.
01/10/2020
 
 
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