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About 1135 results for "us food and drug administration"

PDAC supports effectiveness of Brintellix in treating cognitive dysfunction in MDD

FDA's staffers have favorable view on Celltrion's Remicade bio...

, the Food and Drug Administration's Arthritis Advisory Committee is scheduled to hold an advisory hearing on an application for South Korean firm Celltrion's (Kosdaq: 068270) CT-P13, a biosimilar version of infliximab, currently only available as ... Pharma Letter, 3 hours ago

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Times of India, 5 days ago
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Daily Caller, 2 weeks ago
Business Standard India, 2 weeks ago
BDlive, 2 days ago
The Malaysian Times, 2 weeks ago
Financial Express, 2 weeks ago
Business Insider, 3 weeks ago
Reuters UK, 3 weeks ago
CNN, 2 weeks ago

Gardasil 9: Helping Prevent Cervical Cancer

In late 2014, the U.S. Food and Drug Administration approved Gardasil 9, a vaccine that protects againstnine types of the human papillomavirus (HPV). Gardasil 9 covers a broader range of the HPV virus ascompared to Gardasil, which protects ...
 MySanAntonio17 hours ago
SPi World News

U.S. Food and Drug Administration (FDA) Grants Breakthrough Therapy Designation to Immunomedics for Sacituzumab Govitecan for the Treatment of Patients With Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., Feb. 05, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc. , (Nasdaq:IMMU) today announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from ...
 Bloomberg1 day ago Immunomedics Inc ( IMMU )  Stock Junction1 day ago Immunomedics's Breast Cancer Drug Wins Breakthrough Tag from the FDA  BioSpace1 day ago Here's why Immunomedics, Inc Surged around 30% Today  Bidness Etc1 day ago

FDA reviewers support Celltrion's biosimilar Remicade

Feb 4 (Reuters) - U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc's biosimilar form of blockbuster arthritis drug Remicade indicated it is "highly similar" to the branded product in terms of safety, ...
 Yahoo! Finance1 day ago FDA staff backs biosimilar to Remicade; J&J and AbbVie fall  Reuters1 day ago FDA reviewers support Celltrions biosimilar Remicade  Reuters UK1 day ago FDA staff supports Celltrion's biosimilar Remicade  Yahoo! News1 day ago
Money Control

Aurobindo Pharma gets nod for Isosulfan Blue injection

Aurobindo Pharma Ltd on Wednesday said that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1%, which is used in lymphography procedure. Announcing the receipt of ...
 The Hindu2 days ago Athenex gets FDA OK for clinical trials of oral form of cancer drug  DrBicuspid.com2 days ago Synergy Pharmaceuticals Files New Drug Application For Plecanatide In Chronic Idiopathic Constipation  Drug Discovery Online3 days ago Sun Pharma gains; launches Imatinib Mesylate in US market  Money Control4 days ago
Money Control

Dr Reddy's Laboratories passes US FDA approval for ZEMBRACESymTouch Injection for treating migraines in adults

Pharmaceutical company Dr Reddy's Laboratories (NYSE:RDY) reported on Tuesday the receipt of the US Food and Drug Administration's (FDA) approval for ZEMBRACE SymTouch (sumatriptan succinate) injection for the treatment of acute migraine episodes. ...
 Bloomberg3 days ago Dr Reddy’s gets US FDA nod for antibiotic  Business Line5 days ago Dr Reddy's gets tentative approval from USFDA for Zenavod  Business Standard5 days ago US FDA nod for Dr Reddy’s anti-migraine drug  Business Line1 week ago

IPCA gets US FDA warning for mfg lapses at 3 plants

MUMBAI: Drugmaker IPCA Laboratories Ltd said the US Food and Drug Administration issued it a warning letter highlighting manufacturing quality lapses at three of its Indian factories. The letter concerns the company's Ratlam and SEZ Indore plants in central ...
 Economic Times5 days ago Ipca Labs gets warning letter from USFDA for 3 plants  The Financial Chronicle5 days ago Ipca Labs gets FDA warning for 3 plants  Business Line5 days ago Ipca Laboratories gets USFDA warning letter for 3 facilities; shares down 4%  DNA5 days ago
India Infoline

Sun Pharma scrip gains 4% on launch of generic Gleevec in US next year

Sun Pharma has received approval from the US Food and Drug Administration (USFDA) to launch generic version of its anti-cancer drug Gleevec (Imatinib Mesylate) tablets, 100 mg and 400 mg.
 Times of India2 months ago Lupin launches generic Glumetza in US and other Top Corporate News  India Infoline3 days ago Sun Pharma, Lupin launch generic versions of major drugs in US  Smart Investor4 days ago Sun Pharma, Lupin launch generics in US  Pharma Focus Asia3 days ago
Scientific American

U.S. Panel Greenlights Creation of Male Three-Person Embryos

The U.S. Food and Drug Administration (FDA) should approve clinical trials to transfer DNA from healthy human eggs to diseased embryos, the US National Academy of Medicine said today. The controversial gene-therapy technique involves replacing an ...
 Scientific American3 days ago U.S. Panel Green-Lights Creation of Male 3-Person Embryos  MyInforms3 days ago US panel greenlights creation of male 'three-person' embryos  Journal of Cerebral Blood Flow & Metabolism1 day ago

Lundbeck wins U.S. backing that may extend use of anti-depressant

COPENHAGEN (Reuters) - Denmark's Lundbeck said on Thursday a U.S. Food and Drug Administration (FDA) committee had recommended that its anti-depression drug Brintellix can add improved cognitive functions to its information leaflet, a first of its ...
 Business Insider2 days ago Lundbeck wins US backing that may extend use of anti-depressant  Channel NewsAsia2 days ago
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