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About 1187 results for "us food and drug administration"

Aurobindo gets US nod for seizures treatment drug
Moneycontrol.com

Glenmark receives tentative US FDA approval for generic Epiduo...

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (FDA) for adapalene and benzoyl peroxide gel, 0.1%|2.5%, the generic version of Epiduo gel of Galderma Laboratories ... PharmaBiz, 6 hours ago
Aurobindo gets US nod for seizures treatment drug Moneycontrol.com, 5 hours ago
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Food Safety Magazine

FDA issues final food-safety rule

The U.S. Food and Drug Administration has finalized a new food-safety rule under the Food Safety Modernization Act, designed to prevent food contamination during transportation. The rule will require those involved in transporting food and feed by ...
 Agri View2 days ago Groups Sue to Force FDA to Act on Chemical in Food Packaging  Before It's News17 hours ago OSU names plant pathology and food safety expert to head national research and investigative lab  High Plains Journal1 day ago Global Food Additives Market to Reach US$39.8 bn by 2021 due to Increasing Expansion of Food and Beverage Industry  Press Release Ping2 days ago
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StatNews.com

Sarepta Can Win Speedy FDA Drug Approval

There's a risk to the consensus investor view that the U.S. Food and Drug Administration will reject Sarepta Therapeutics' (SRPT - Get Report) Duchenne muscular dystrophy drug eteplirsen following Monday's negative advisory panel. Senior FDA ...
 TheStreet.com1 day ago FDA Still Negative on Sarepta's DMD Drug; Stock Price Sinks  TheStreet.com1 week ago FDA review raises fresh doubts that Sarepta DMD drug will be approved  StatNews.com1 week ago Sarepta shares sink as FDA staff stay sour on muscle disorder drug  Sharenet1 week ago
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Reuters

US FDA grants breakthrough therapy designations for Novartis' Ilaris to treat rare types of periodic fever syndromes

The US Food and Drug Administration (FDA) has granted three Breakthrough Therapy Designations for Novartis' Ilaris (canakinumab) to treat three rare types of periodic fever syndromes, also known as hereditary periodic fevers. This means Novartis ...
 PharmaBiz1 day ago US Breakthrough designations granted for Novartis Ilaris for rare periodic fever syndromes  Pharma Letter1 day ago Novartis Ilaris gets US FDA breakthrough therapy designation to treat fever syndromes  Pharmafile2 days ago FDA gives ocrelizumab breakthrough designation for PPMS: Roche  Reuters2 months ago
Money Control

Torrent recalls 20,952 cartons of hypertension drug in US

The tablets in the strength of 80 mg are made by Torrent for its US arm Torrent Pharma Inc, the latest US Food and Drug Administration (USFDA) enforcement report said.
 Money Control1 day ago Torrent Pharma Recalls 20,952 Cartons Of Hypertension Drug In US: Regulator  NDTV Profit1 day ago

GW Pharmaceuticals Gets Orphan Drug Designation For Tuberous Sclerosis

LONDON (Alliance News) - GW Pharmaceuticals PLC said Thursday that the US Food and Drug Administration has granted an orphan drug designation for cannabidiol for the treatment of Tuberous Sclerosis Complex, a rare genetic disorder which commonly ...
 London Stock Exchange1 week ago Fibrocell Receives Orphan Drug Designation From The FDA For FCX-013 For The Treatment Of Localized Scleroderma  TheStreet.com4 days ago FIBROCELL SCIENCE : Receives Orphan Drug Designation from the FDA for FCX-013 for the Treatment of Localized Scleroderma  4 Traders2 days ago Fibrocell awarded US FDA orphan drug designation for FCX-013 for treating localised scleroderma  Bloomberg3 days ago
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Tech Times

Another Fatal-Disease Drug in Limbo

WIKIMEDIAAn advisory panel for the US Food and Drug Administration (FDA) voted this week (April 25) that Sarepta Therapeutics's eteplirsen has not been proven effective in the treatment of Duchenne muscular dystrophy (DMD), a rare and fatal disease ...
 The Scientist1 day ago Rounding Up the Experts??? Thoughts on What's Next for Sarepta's DMD Drug  BioSpace1 day ago FDA Panel Gives Thumbs Down To Sarepta Duchenne Muscular Dystrophy Drug Eteplirsen  Tech Times2 days ago FDA Panel???s 7-6 Vote Against Sarepta???s DMD Drug Underlines Battle Between Science and Patient Advocates  BioSpace2 days ago
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Panic signals in India as USFDA asks drug companies to repeat Semler's studies

MUMBAI|NEW DELHI: A note from the US Food and Drug Administration (FDA) informing drug companies last week about data integrity concerns at Semler Research has sent panic signals across the Indian pharmaceutical industry. The US agency had called ...
 Economic Times4 days ago FDA warns Semler over research data  The Hindu6 days ago US Food and Drug Administration issues data integrity notice to Indian CRO Semler  Economic Times1 week ago
HCPLive

fda approves supplemental nda for abbvies viekira pak hepatitis c drug

The US Food and Drug Administration approved a supplemental New Drug Application submitted by drug maker AbbVie for Viekira Pak without ribavirin to treat patients with chronic hepatitis C genotype 1b and compensated cirrhosis. Originally ...
 HCPLive1 day ago AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAKĀ® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis  TickerTech.com4 days ago Enanta Announces U.S. FDA has Approved AbbVie's Supplemental New Drug Application for Use of VIEKIRA PAKĀ® without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis  Bloomberg4 days ago 4/27/16 - United States : AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK (ombitasvir, paritaprevir, and ritonavir... [TendersInfo (India)]  Pharmacy Choice2 days ago
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Boston Scientific's ImageReady MR-Conditional Pacing System receives US FDA approval

Boston Scientific, a global medical technology leader, has received US Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady MR-Conditional Pacing ...
 PharmaBiz2 days ago Stock Update (NYSE:BSX): Boston Scientific Receives U.S. FDA Approval For ImageReady MR-Conditional Pacing System  MoneyShow.com3 days ago BOSTON SCIENTIFIC : Receives U.S. FDA Approval For ImageReady MR-Conditional Pacing System  4 Traders3 days ago Boston Scientific Receives U.S. FDA Approval For ImageReady MR-Conditional Pacing System  EP Lab Digest1 day ago
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