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About 1138 results for "us fda"

U.S. FDA panel reviews Baxter immune therapy's long-term safety

Advisors to the U.S. Food and Drug Administration will meet on Thursday to discuss the relative risks and benefits of Baxter International Inc's experimental treatment for certain hereditary disorders of the immune system. The FDA on Wednesday ... Reuters, 1 hour ago
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Seniors to FDA: Safety in biosimilars

Biologics are truly miracle drugs. Made from living cells, they have revolutionized the treatment of multiple sclerosis, HIV, hepatitis C, rheumatoid arthritis and range of other diseases. While the introduction of biosimilar medications, which ...
 The Hill2 hours ago
CNBC

FDA expanded use of eye drug

Regeneron Pharmaceuticals said the U.S. Food and Drug Administration has approved the expanded use of its eye drug Eylea for the treatment of diabetic macular edema. The condition causes swelling of an oval spot within the retina in the eyes of ...
 CNBC19 hours ago FDA approves Regeneron's Eylea for DME treatment  Seeking Alpha22 hours ago FDA Oks expanded use of Regeneron's eye drug  Yahoo! India22 hours ago FDA gives Regeneron OK to market Eylea for treatment of diabetic macular edema  MedCity News9 hours ago
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Daily Rx

BRIEF: Medical startup seeks FDA approval for lung-disease product [The Sacramento Bee :: ]

July 29--A Sacramento medical-device startup and its partners are about to seek U.S. Food and Drug Administration approval for its first product, a home-purification system aimed at fighting lung infections in cystic fibrosis patients. The Asthma & ...
 BusinessWeek23 hours ago FDA Expands Approval of Rx for Rare Blood and Bone Disease  Daily Rx1 day ago FDA Approves Imbruvica for Treating Chromosome 17-Deletion CLL Patients  American Journal of Managed Care2 days ago FDA expands approved use of Imbruvica for chronic lymphocytic leukemia  Food Consumer2 days ago
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Reuters

7/30/14 - CorMatrix Gets FDA Approval to Market ECM for Vascular Repair [Professional Services Close - Up]

CorMatrix Cardiovascular reported that it has received U.S. Food and Drug Administration clearance to market the CorMatrix ECM for Vascular Repair. According to a release from the company, the CorMatrix ECM for Vascular Repair is intended for use ...
 Pharmacy Choice9 hours ago Ranbaxy gets nod for new generic BP drug  Business Line1 month ago Ranbaxy gets FDA approval for Novartis's Diovan generic  Reuters1 month ago Ranbaxy, Sun Pharma up 6-8% on US FDA nod; analysts bullish  Money Control1 month ago
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Mashable

Is That App FDA Approved? Mobile Health Tech Falls Into Gray Area

The iHealth MyVitals app and a mobile blood pressure monitoring dock. By Bahar Gholipour, Staff Writer for LiveScience 2014-07-30 17:45:19 UTC Personal health is becoming increasingly mobile, and there are now thousands of apps aiming to address ...
 Mashable3 hours ago Robust FDA oversight needed to ensure consumer safety, confidence in mobile health app market  Medical News Today11 hours ago Booming mobile health app market needs more FDA oversight for consumer safety, confidence  ECN1 day ago Law Experts: Mobile Health Apps Need More FDA Regulation  Laboratory Equipment2 days ago
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New US clearance expands the indications for which clinicians will be able to use a real-time tracking device for monitoring motion during radiotherapy treatments for cancer.

Varian Medical Systems (Palo Alto, CA, USA) has received 510(k) clearance from the US Food and Drug Administration (FDA) for a Calypso soft tissue Beacon transponder that can help enhance the precision of radiotherapy and radiosurgery treatments for ...
 MedImaging.net4 hours ago

Adamis Pharmaceuticals' NDA for EPINEPHRINE INJECTION, USP accepted for US FDA's review

Biopharmaceutical company Adamis Pharmaceuticals (NASDAQ:ADMP) reported on Tuesday the US Food and Drug Administration's (FDA) acceptance of its New Drug Application (NDA) for EPINEPHRINE INJECTION, USP, 1:1000 for review for the emergency treatment ...
 Individual.com10 hours ago FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe  Wall Street Select1 day ago FDA accepts to review Adamis' NDA for Epinephrine pre-filled syringe  Pharmaceutical Business Review5 hours ago FDA Accepts For Review Adamis Pharmaceuticals' New Drug Application For Its Epinephrine Pre-Filled Syringe  BioSpace1 day ago
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US News & World Report

FDA Should Not Regulate E-Cigarettes as Tobacco Products

The Food and Drug Administration's Center for Tobacco Products has two goals that seem to go hand-in-hand: Reduce tobacco use, and reduce the number of smoking-related diseases and deaths. If there was a product that was achieving both goals, why ...
 US News & World Report9 hours ago
PRWeb

FDA Refines Its Understanding And Validation Within The Contexts Of Process Validation Terminology

The FDA has refined its understanding and validation for product, software and processes used for medical production. Protomatic demonstrates its method for adopting the four protocol: design qualification (DQ), installation qualification (IQ), ...
 PRWeb14 hours ago
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