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Tag: fda
Merck blood thinner gets 'yes' vote from FDA panel
2014-01-16 01:29:48| Biotech - Topix.net
A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding.
Merck Statement on FDA Advisory Committee for Vorapaxar, Mercks Investigational Antiplatelet Medicine
2014-01-16 00:59:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today said it was pleased with the U.S. Food and Drug Administration (FDA)s Cardiovascular and Renal Drugs Advisory Committees recommendation for approval of vorapaxar. Vorapaxar is the companys investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orPatrick Witmer, 267-305-4910orInvestors:Carol Ferguson, 908-423-4465orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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medicine
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advisory
Varian Medical Systems Receives FDA 510(k) Clearance for Its ProBeam(TM) Proton Therapy System
2014-01-15 06:00:00| Industrial Newsroom - All News for Today
PALO ALTO, Calif. — Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system.<br /> <br /> Varian's ProBeam system gives clinicians options for delivering dose precisely in order to minimize dose to healthy tissue in the course of delivering proton therapy treatments for cancer. Its scanning beam technology enables intensity-modulated proton therapy (IMPT) by modulating dose levels on a spot-by-spot basis throughout the ...This story is related to the following:Radiotherapy Systems
Tags: system
systems
medical
therapy
Johnson & Johnson Faces Uphill Battle At FDA Advisory Panel
2014-01-15 00:47:09| Food - Topix.net
The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson's Xarelto .
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johnson
battle
faces
J&J petitions FDA to require "similar" names for biosimilars, biologics
2014-01-09 10:10:28| Food - Topix.net
Johnson & Johnson on Wednesday said it submitted a citizen petition asking that U.S. health regulators require copies of biological products to bear names that are similar and not identical to those of their reference products.
Tags: similar
require
names
fda
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