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About 800 results for "pdufa"

A Comprehensive Comparison Of Gilead's Harvoni And AbbVie's Triple HCV Regimen: What The HCV Marketplace May Look Like In 2015 And Beyond
Seeking Alpha

The FDA May Find Some Use For Rapivab And Approve The Influenz...

Summary Rapivab may just pass its December 23 PDUFA date with the FDA based on one conclusive Phase 2 result over placebo and minimal safety issues. Rapivab's only effective formulation (IV infusion) limits its utility and earning potential. Seeking Alpha, 1 day ago

1 images for "pdufa"

Seeking Alpha, 1 month ago

PDUFA date approaches for BioCryst flu drug

To screen ETFs by asset class, performance, yield and more, check out the ETF Hub.
 Seeking Alpha1 day ago

PDUFA date approaches for Jakafi label expansion myelofibrosis

Friday, December 5 is the PDUFA date for the FDA's review of Incyte's (INCY -1.7%) Jakafi (ruxolitinib) sNDA for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is ...
 Seeking Alpha2 weeks ago FDA clears Jakafi for PV  Seeking Alpha2 weeks ago

2nd Half Of 2014 Biotechnology Catalysts: Part 5

Summary PDUFA decisions have the potential to increase share prices as investor anticipation and attention grows in advance of the FDA decision. The primary catalysts that we are looking for when investing in a catalytic event is a PDUFA date (a ...
 Seeking Alpha2 weeks ago

Salix Pharmaceuticals Provides Updates on Wholesaler Inventory Reductions and the XIFAXAN® 550 for IBS-D Approval Timeline, and Provides Preliminary Guidance for 2015 and 2016

Expects to Achieve Wholesale Inventory Targets by Year End 2015 Announces Extension of PDUFA Action Date for XIFAXAN 550 for IBS-D to May 27 Provides Preliminary Guidance for Full Years 2015 and 2016 RALEIGH, N.C.--(BUSINESS WIRE)--Dec. 16, ...
 BusinessWeek3 days ago Salix Pharmaceuticals : Provides Updates on Wholesaler Inventory Reductions and the XIFAXAN® 550 for IBS-D Approval Timeline, and Provides Preliminary Guidance for 2015 and 2016  4 Traders3 days ago Salix Pharmaceuticals Sees 2015 Below Estimates  Earnings Whispers3 days ago
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Inside Health Policy - Industry Looks At 21st Century Cures To Set Stage For PDUFA VI

Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the ...
 Friends of Cancer Research4 hours ago

UPDATED: As PDUFA looms Sanofi punts a $35M partnership

A little more than a year after Sanofi ( $SNY ) stepped in to sign a development deal with Pozen, the pharma giant has stepped back out just weeks ahead of a scheduled PDUFA date. Chapel Hill, NC-based Pozen ( $POZN ) says the pharma giant and the ...
 FierceBiotech2 weeks ago Pozen and Sanofi US End Agreement for PA8140/PA32540  Individual.com2 weeks ago POZEN and Sanofi Terminate Partnership for PA8140/PA32540  PharmaceuticalProcessing2 weeks ago Up-to-$35M Sanofi-Pozen Partnership Ends for Advanced Aspirins  Genetic Engineering News2 weeks ago
Forbes.com

FDA approves Cubist's Zerbaxa

Editor The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated ...
 Seeking Alpha10 minutes ago FDA Approves Second Cubist Antibiotic Of 2014  Forbes.com16 minutes ago

Amarantus Bioscience Holdings, Inc. (AMBS: OTCQB) | Amarantus Submits Orphan Drug Designation Application to US FDA for Treatment of Retinal Artery Occlusion With Product Candidate MANF

SAN FRANCISCO and GENEVA, Dec. 19, 2014 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the development of diagnostics in Alzheimer's disease and therapeutic products in the areas of ...
 Pink Sheets10 hours ago Amarantus Submits Orphan Drug Designation Application to US FDA for Treatment of Retinal Artery Occlusion With Product Candidate MANF  Stockwatch11 hours ago Amarantus BioSciences, Inc. Submits Orphan Drug Designation Application To U.S. FDA For Treatment Of Retinal Artery Occlusion With Product Candidate MANF  BioSpace8 hours ago
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Pharma Letter

Public Meeting on Patient-Focused Drug Development for Breast Cancer; Request for Comments

Notice of public meeting; request for comments. Citation: "79 FR 75822" Document Number: "Docket No. FDA-2014-N-2137" Page Number: "75822" "Notices" SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public ...
 Pharmacy Choice5 hours ago Patient-Focused Drug Development Public Meeting on Chagas Disease  Pharmacy Choice1 week ago FDA Focus: Life-threatening disease and the benefit-risk of treatment options  Pharma Letter1 week ago
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