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About 1073 results for "fda"

FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes
US News & World Report

FDA approves life-changing diabetes monitor

WASHINGTON — Federal regulators have approved a first-of-a-kind artificial pancreas, a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed. The device from ... New York Post, 1 hour ago
FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes US News & World Report, 11 hours ago
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PharmaVOICE, 7 hours ago
ADVFN UK, 4 hours ago
Drug Watch, 2 days ago
Monthly Prescribing Reference, 2 days ago
Renal & Urology News, 1 day ago
Monthly Prescribing Reference, 2 days ago
ODT Mag, 1 hour ago
ODT Mag, 1 hour ago
California Healthline, 1 day ago
Monthly Prescribing Reference, 2 days ago

FDA approves expanded use of Vertex's CF drug Orkambi; 2016 revenue guidance lowered; shares off 2% after hours

The FDA approves the use of Vertex Pharmaceuticals' (NASDAQ: VRTX ) ORKAMBI (lumacaftor/ivacaftor) for use in children ages 6 through 11 with cystic fibrosis (CF) who have two copies of the F508del mutation. It was previously approved for patients ...
 Seeking Alpha11 hours ago BRIEF-U.S. FDA approves Orkambi for use in children with Cystic Fibrosis  Reuters UK11 hours ago FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation  Drugs.com3 hours ago REUTERS - FDA approves expanded use of Vertex Pharma's cystic fibrosis drug  Namibia Press Agency10 hours ago
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Food DIVE

FDA to revise regulations defining healthy labeling

After repeated demands, the US Food and Drug Administration decided on Tuesday to redefine the decades-old definition of the term healthy used on food labels. The step is being taken after the current regulations being repeatedly referred to as ...
 French Tribune17 hours ago WATCH: FDA Takes Steps to Redefine 'Healthy'  ABC News18 hours ago Redefining 'healthy': FDA revisits a controversial term by Carolyn Heneghan 19 hours ago  Food DIVE51 minutes ago FDA to define healthy for food labeling  Institute of Food Technologists7 hours ago
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Next Science„¢ Irrigation Solution Gains FDA Approval

JACKSONVILLE, Fla. , Sept. 28, 2016 /PRNewswire/ -- Next Science, LLC is excited to announce the approval of Next Science Irrigation Solution by the FDA for the irrigation and debridement of wounds. Next Science Irrigation Solution is an exciting ...
 TickerTech.com7 hours ago Next Science Irrigation Solution Gains FDA Approval  Yahoo! Finance7 hours ago Next Science? Irrigation Solution Gains FDA Approval  Pharmacy Choice9 minutes ago Next Science(TM) Irrigation Solution Gains FDA Approval  Biotechgate1 hour ago
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Biotech Stocks Facing FDA Decision In October

The case in point is Sarepta Therapeutics (SRPT), which has soared over 121 percent, in the 8 trading sessions following the company's announcement of getting accelerated approval for its Duchenne muscular dystrophy drug Exondys 51. That said, the ...
 Nasdaq48 minutes ago

FDAnews Announces -- Special Protocol Assessments: Decoding FDA's SPA Program and Revised Guidance Webinar, Oct. 26, 2016

PRWeb Special Protocol Assessments: Decoding FDA's SPA Program and Revised Guidance **An FDAnews Webinar** Oct. 26, 2016 -- 1:30 p.m. - 3:00 p.m. ET http://info.fdanews.com/special-protocol-assessments-pr How should manufacturers use SPAs ...
 International Business Times1 hour ago FDAnews Announces — Special Protocol Assessments: Decoding FDA's SPA Program and Revised Guidance Webinar, Oct. 26, 2016 September 29, 2016How should manufactu​rers use SPAs to get feedback from the FDA on clinical trial design? Join Alexander Varond — As  PRWeb1 hour ago
NPR

A Look At How The Revolving Door Spins From FDA To Industry

 NPR17 hours ago 'Revolving Door' Between the FDA and Industry?  Diabetes Care1 day ago When Drug Reviewers Leave The FDA, They Often Work For Pharma  Washington Post1 day ago A revolving door between FDA and the pharma industry raises questions about 'whether regulators indefatigably act in the public interest'  Business Insider Australia1 day ago
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QMED

FDA OKs Abbott's FreeStyle Libre Pro continuous glucose monitoring system

The FDA approves Abbott's ( ABT -0.4%) FreeStyle Libre Pro, a continuous glucose monitoring system featuring the Ambulatory Glucose Profile, a visual snapshot of glucose data that includes patterns and trends that enable healthcare professionals to ...
 Seeking Alpha18 hours ago Abbott gets FDA clearance to bring FreeStyle Libre Pro CGM to US  Mobihealthnews10 hours ago Abbott Wins FDA Approval for Innovative Glucose Monitor  QMED12 hours ago Abbott wins FDA nod for Freestyle Libre Pro  MassDevice17 hours ago
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Monthly Prescribing Reference

Summit Receives Fast Track Designation From US FDA for Ezutromid in the Treatment of Duchenne Muscular Dystrophy

OXFORD, United Kingdom, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (DMD) and Clostridium difficile infection, ...
 Drugs.com4 hours ago FDA designates Summit's ezutromid as Rare Pediatric Disease for treatment of Duchenne muscular dystrophy  Seeking Alpha1 day ago Soricimed's SOR-C13 Granted Orphan Drug Designation for Pancreatic Cancer by the U.S. FDA  Pharmacy Choice1 day ago FDA Encourages Collaborative and Innovative Approach to Clinical Trial Designs  ASH Clinical News1 day ago
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StatNews.com

Amgen's Humira Biosimilar Becomes the Fourth FDA Approved Biosimilar

On Friday, September 23, the FDA approved its fourth biosimilar, Amgen's biosimilar version of AbbVie's Humira®. Amgen's biosimilar, Amjevita®, has been approved for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic ...
 JD Supra10 hours ago Does the FDA have a high enough standard for drug approvals?  StatNews.com12 hours ago Amgen's Amjevita approved by the FDA as the first biosimilar to blockbuster Humira  DataMonitor HealthCare16 hours ago US FDA approves Amgen's Amjevita to treat inflammatory diseases  PharmaBiz1 day ago
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