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About 1152 results for "us fda"

Bristol-Myers/Pfizer's Eliquis Gets Yet Another FDA Nod

Bristol-Myers Squibb Company ( BMY ) and partner Pfizer ( PFE ) announced that the FDA has cleared their anti-clotting drug Eliquis for an additional indication. The U.S. regulatory body cleared the drug for the treatment of deep vein thrombosis ( ... Yahoo! Finance, 23 hours ago

259 images for us fda

Med India, 1 day ago
Asiaone, 1 week ago
Pharma Letter, 1 week ago
Bio Spectrum Asia, 2 weeks ago, 2 weeks ago
Bio Spectrum Asia, 3 days ago
PRWeb, 2 days ago
Business Standard India, 1 day ago
Pharma Letter, 1 day ago
PRWeb, 3 weeks ago
International Business Times UK

US Health Authorities Refuse Eye Donations From Dead Gay Teen

By | IB Times The US Food and Drug Administration (FDA) has refused to accept eyes donated by a dead teenager, because he was gay. Alexander Betts Jr, 16, took his own life last year after being bullied at school. His heart, lungs and kidneys ...
 Yahoo! Singapore2 hours ago

Eliquis approved in US to treat DVT & PE and for reduction in risk of recurrent DVT and PE following initial therapy

Bristol-Myers Squibb Company and Pfizer announced the US Food and Drug Administration (US FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT ...
 PharmaBiz16 hours ago FDA Grants Label Expansion For Bristol-Myers And Pfizer's Blood-Thinning Drug  Bidness Etc1 day ago GlaxoSmithKline's (GSK) Arnuity Ellipta Approved by FDA  Yahoo! Finance1 day ago FDA Approves Apixaban (Eliquis) for DVT/PE Treatment  Diabetes Care2 days ago
MSN India

Now, smartphones can help detect irregular heartbeat

AliveCor in San Francisco has announced that the US Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib)
 MSN India1 day ago AliveCor Receives FDA Clearance to Detect AF in Smartphone ECG Device  Diagnostic & Invasive Cardiology19 hours ago UPDATED: FDA clears first smartphone-based device to detect atrial fibrillation  FierceMedicalDevices1 day ago First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device  Medical Design Technology2 days ago

Emergent submits biologics license application for anthrax therapy to FDA

Emergent BioSolutions Inc., a biopharmaceutical company, has submitted a biologics license application to the FDA for anthrax immune globulin intravenous, or human AIGIV. AIGIV is developed as part of a development contract with the Biomedical ...
 Individual.com5 hours ago

US FDA granted marketing nod for zinc transporter 8 autoantibody test to diagnose type 1diabetes

The US Food and Drug Administration (FDA) allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient ...
 PharmaBiz14 hours ago FDA Clears Blood Test to Help Diagnose Type 1 Diabetes  Diabetes Care2 days ago FDA Allows Marketing of ZnT8Ab Test to Help Diagnose Diabetes  RxList1 day ago First-Ever Diagnostic Test for T1DM Receives FDA Approval  American Journal of Managed Care2 days ago

Physicians urge FDA to allow distinctive names for biosimilars

A coalition of organizations representing specialist physicians and individual physicians have authored a letter to U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg calling on the agency to allow biosimilar drug products to have ...
 Lexology22 hours ago

Assessing FDA's Final Guidance on Companion Diagnostics

On the same day that FDA released its draft guidances on regulating laboratory-developed tests (LDT), the agency also issued a final guidance on the development, review, and clearance of companion diagnostics. According to FDA, this guidance is ...
 Medical Design Technology22 hours ago

ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection

LONDON, Aug. 22, 2014 /CNW/ -- ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ...
 BusinessWeek1 day ago FDA approves ViiV Healthcare's Triumeq tablets for treatment of HIV-1 infection  News-Medical.Net13 hours ago GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment  FierceBiotech1 day ago FDA Approves for Triumeq (abacavir, dolutegravir and lamivudine) for the treatment of HIV-1 Infection  Drugs.com16 hours ago
Med India

FDA approves more innovative med tech, faster in first half

The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from ...
 FierceMedicalDevices23 hours ago Genzyme receives FDA approval for label expansion of Pompe disease drug in US  Individual.com2 days ago Genzyme wins US FDA's approval for Cerdelga capsules for Gaucher Disease Type 1  Individual.com3 days ago FDA approves Cerdelga for Type 1 Gaucher disease treatment  Big News Network2 days ago
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