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TXT FDA Approves Lilly’s Jardiance to Reduce CV Death [1154 Words] [ Price : $8.95]
FDA approves a new indication for Eli Lilly’s Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and cardiovascular disease.
12/02/2016
 
 
TXT FDA Steps to Improve Combination Product Review [1148 Words] [ Price : $8.95]
FDA steps up its focus on combination products and plans to finalize its guidance on human factors and GMPs this coming year.
12/02/2016
 
 
TXT Guide on Clinical Pharmacology Drug Labeling [1183 Words] [ Price : $8.95]
FDA releases a guidance on the “Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format” that offers recommendations on preparing this section in prescription drug labeling.
12/02/2016
 
 
TXT Biostage Granted Orphan Status for Esophagus Cell Regenerator [263 Words] [ Price : $8.95]
FDA grants Biostage an orphan drug designation for Cellspan Esophageal Implant to restore the structure and function of the esophagus after esophageal damage from cancer, injury or congenital abnormalities.
12/02/2016
 
 
TXT Regulatory Review Period Established for Pfizer’s Trumenba [73 Words] [ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Pfizer’s meningitis B vaccine Trumenba for patent term extension purposes.
12/02/2016
 
 
TXT FDA Clears Nanowear SimplECG Device [108 Words] [ Price : $8.95]
FDA clears a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment.
12/02/2016
 
 
TXT Draft Guide on Pharmacokinetic Analyses Format and Content [1109 Words] [ Price : $8.95]
Federal Register Notice: FDA posts a draft guidance on “Physiologically Based Pharmacokinetic Analyses — Format and Content.”
12/02/2016
 
 
TXT Medtronic Recalls Neurovascular Products [2672 Words] [ Price : $8.95]
FDA says Medtronic has recalled four neurovascular products due to the risk of coating separation and detachment.
12/01/2016
 
 
TXT Cures Act Promises FDA $500 mil. More, Heads to Senate [2468 Words] [ Price : $8.95]
After a 392-26 passage in the House, the 21st Century Cures Act heads to the Senate and could see a vote as early as next week.
12/01/2016
 
 
TXT FDA Priority Review for Merck’s Keytruda in Lymphoma [1297 Words] [ Price : $8.95]
FDA accepts for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with refractory classical Hodgkin lymphoma.
12/01/2016
 
 
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