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TXT OPKO Health Files NDA for Hyperparathyroidism Therapy [164 Words] [ Price : $8.95]
FDA accepts for review an OPKO Health NDA for Rayaldee (calcifediol) modified-release capsules, indicated for preventing and treating secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.
07/29/2015
 
 
TXT Issues in State Biosimilar Laws [320 Words] [ Price : $8.95]
Mintz Levin attorneys review issues they say are being raised by state laws regulating biosimilar substitution.
07/29/2015
 
 
TXT FDA Reports Progress on Regulatory Science Goals [665 Words] [ Price : $8.95]
An FDA progress report says the agency has implemented many of its Science Board’s 2007 recommendations for improving the scientific infrastructure, management, and application of regulatory science to enhance its regulatory mission.
07/29/2015
 
 
TXT FDA Clears Corvida Halo Drug Transfer Device [109 Words] [ Price : $8.95]
FDA clears a Corvida Medical 510(k) for the Halo Closed System Transfer Device and its use to protect health care professionals from exposure to hazardous drugs.
07/29/2015
 
 
TXT Stomach Balloon for Weight Loss Approved [304 Words] [ Price : $8.95]
FDA approves a ReShape Medical PMA for the ReShape Integrated Dual Balloon for treating obesity without the need for intensive surgery.
07/29/2015
 
 
TXT Sanofi Reports Favorable Phase 3 Data in Diabetes Trial [240 Words] [ Price : $8.95]
Sanofi says its LixiLan-O Phase 3 clinical trial met its primary objective in patients with Type 2 diabetes treated with metformin.
07/29/2015
 
 
TXT Criminal Charges Sought Against Man Violating Consent Decree [174 Words] [ Price : $8.95]
The U.S. government pursues criminal contempt sanctions against a Livingston, MT, man for selling dietary supplements and drugs in violation of two court orders.
07/29/2015
 
 
TXT Stem Cell Bill Approved in Committee [211 Words] [ Price : $8.95]
The House Energy and Commerce Committee approves and sends to the House floor the Stem Cell Therapeutic and Research Authorization Act of 2015.
07/29/2015
 
 
TXT Bio-Rad Inspection Finds CGMP Violations [294 Words] [ Price : $8.95]
FDA cites Germany’s Bio-Rad Medical Diagnostics for alleged CGMP violations in its manufacturing of several blood products.
07/28/2015
 
 
TXT Essure ‘Harmed’ Women Plan Hunger Strike at FDA [702 Words] [ Price : $8.95]
A group of women allegedly harmed by Bayer’s Essure system for permanent female sterilization say they plan to begin a hunger strike at FDA headquarters following a 9/24 Medical Devices Advisory Committee Obstetrics and Gynecology Panel meeting there.
07/28/2015
 
 
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