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About 1296 results for "us fda"

Genmab/GSK receive FDA sBLA approval for Arzerra in combinatio...

GlaxoSmithKline plc (LSE: GSK) and Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra ® (ofatumumab), a CD20-directed ... News-Medical.Net, 32 minutes ago
US FDA approves ofatumumab Express Pharma, 2 days ago
FDA Grants Full Approval to Ofatumumab (Arzerra) for CLL General Medicine eJournal, 3 days ago
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1,198 images for us fda

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Medical Devices Business Review

Boehringer Ingelheim´s AML drug, volasertib receives orphan drug status in US & EU

The US Food and Drug Administration (FDA) and the European Commission have granted orphan drug designation for Boehringer Ingelheim's volasertib for the treatment of patients with acute myeloid leukaemia (AML). AML is an aggressive cancer of the ...
 PharmaBiz3 hours ago Breathe Technologies gets US FDA 510(k) clearance to its NIOV System for use with compressed gas  PharmaBiz2 days ago FDA Clears Breathe Tech's NIOV System For Respiratory Insufficiency  Pharmaceutical Online3 days ago Boehringer Ingelheim´s Volasertib gets orphan drug designation in EU, US  Bio Spectrum Asia3 days ago
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Pharmaceutical Technology

4/20/14 - Dyax Receives FDA Approval to Expand Use of KALBITOR® ecallantide for the Treatment of Acute Attacks of Hereditary Angioedema to Patients 12 Years of...

Dyax Receives FDA Approval to Expand Use of KALBITOR ecallantide for the Treatment of Acute Attacks of Hereditary Angioedema to Patients 12 Years of Age and Older By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA Dyax Corp.
 Pharmacy Choice20 hours ago Merck receives FDA approval for ragweed pollen-induced allergic rhinitis drug  Individual.com2 days ago Allergy Pills Newly Approved by FDA Could Provide Relief  The Guardian Express2 days ago FDA OKs Ragwitek Hay Fever Tablet  MedPage Today2 days ago
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Business Standard

US regulator stifles Indian drug exports

Bans imposed by FDA on Indian firms in world's largest drug market take a toll Sushmi Dey | New Delhi April 19, 2014 Last Updated at 21:28 IST India's drug export growth in 2013-14 may have dipped sharply from the projected 16-17 per cent to six-seven per ...
 Business Standard1 day ago US Food and Drug regulator to deploy more inspectors in India  Economic Times2 months ago Indian Medicines Come Under Increased Scrutiny: U.S. FDA  Silicon India2 months ago India questions FDA actions on drug firms  Deccan Herald2 months ago
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Internet pharmacy racket: FDA lodges FIRs against nine, including 5 suppliers

In a major crackdown against the illegal export of drugs to foreign countries, the Food and Drug Administration (FDA) has seized drugs worth Rs2.47 crore from 28 locations in three months. It has also registered FIRs against nine people, including ...
 DNA India1 day ago
CBS News

FDA Warns Against Morcellation in Hysterectomy

Laparoscopic power morcellators should no longer be used for hysterectomy or myomectomy in most women with uterine fibroids because of the risk of spreading unsuspected cancerous tissue, the US Food and Drug Administration (FDA) announced today. ...
 Diabetes Care3 days ago FDA warns of cancer risk with fibroid procedure  Denver Post3 days ago FDA Warns Against Hysterectomy Technique That May Spread Cancer  Yahoo! News3 days ago FDA Warns Against Procedure for Uterine Fibroids  Health Finder3 days ago
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Reuters India

FDA now discourages hysterectomy, fibroid procedure

The U.S. Food and Drug Administration said Thursday that a procedure commonly used during hysterectomies and fibroid surgeries can spread undetected cancer. The procedure, called power morcellation, is used to grind up tissue so it can be removed ...
 USA Today3 days ago FDA warns common uterine fibroid surgery can spread undetected cancer  CNBC3 days ago UPDATE 1-FDA warns common uterine fibroid surgery can spread undetected cancer  Reuters3 days ago
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Med India

Syneron Medical's CEO Discusses FDA Clearance of the UltraShape System - Conference Call Transcript

Syneron Medical Ltd., ( ELOS ) FDA Clearance of the UltraShape System Conference Call April 17, 2014 8:30 AM ET Operator Good day, ladies and gentlemen and welcome to the Syneron Medical Ltd., Conference Event. At this time, all participants ...
 Seeking Alpha3 days ago US FDA grants marketing approval to Syneron Medical's UltraShape System for fat cell destruction  PharmaBiz4 days ago FDA clearance to market the UltraShape System  Today's Medical Developments4 days ago Syneron to Host Conference Call and Webcast to Discuss UltraShape FDA Clearance  TickerTech.com4 days ago
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Medical Design Online

US FDA approves Boston Scientific's innovative new defibrillators & heart failure devices

The US Food and Drug Administration (FDA) has approved Boston Scientific Corporation's latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the Dynagen Mini and Inogen ...
 PharmaBiz4 days ago Boston Scientific wins US FDA approval for new generation ICDs and CRT-Ds defibrillators and heart failure devices  MENAFN4 days ago Boston Sci gains FDA approval for devices in X4, Mini line  Medical Device Daily4 days ago BSX wins FDA approval on heart devices  WBJournal.com4 days ago
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Rediff.com

Glenmark's insomnia drug, eszopiclone tablets receives US FDA approval

Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for eszopiclone tablets. Glenmark will commence ...
 PharmaBiz4 days ago PTI - DRL-GLENMARK(BCM9) - Dr Reddy's launches insomnia drug in US; Glenmark gets FDA nod  Namibia Press Agency4 days ago Dr Reddy's launches insomnia drug in US; Glenmark gets FDA nod  Economic Times4 days ago Dr Reddy’s launches insomnia drug in US, Glenmark gets FDA nod  Business Line4 days ago
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