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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

2016-03-07 14:00:00| Merck.com - Corporate News

Dateline City: KENILWORTH, N.J. Application Based on Data from KEYNOTE-010, Which Showed Superior Overall Survival for Patients Taking KEYTRUDA Compared to Chemotherapy in Patients with PD-L1 Expression on One Percent or More of the Cancer Cells KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the companys anti-PD-1 therapy, to include data from KEYNOTE-010. Language: English Contact: MerckMedia:Pamela Eisele, (267) 305-3558orKim Hamilton, (908) 740-1863orInvestor:Teri Loxam, (908) 740-1986orJustin Holko, (908) 740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced application license cell

FDA Releases Revised AOC Codes

2016-03-07 09:00:00| Expeditors Newsflash - Americas Edition

Expeditors Newsflash - Americas Edition

Tags: releases codes revised fda

CSL haemophilia B drug gets Us Fda approval

2016-03-07 02:18:24| Biotech - Topix.net

Biotech giant CSL's long-awaited haemophilia B drug, Idelvion, will be available imminently in the key United States market after the drug was approved by the US Food & Drug Administration. "Idelvion has the potential to significantly impact the treatment of haemophilia B as it maintains factor nine activity levels above 5 per cent over a prolonged of time.

Tags: drug approval fda csl