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About 1146 results for "us fda"

FDA approves new Vertex's drug

Vertex Pharmaceuticals Incorporated Soars Following FDA Approv...

Vertex Pharmaceuticals Inc. ( NASDAQ:VRTX ) stock shot up over 4% during Thursday's trading as the company secured approval from the US Food and Drug Administration (FDA) for its cystic fibrosis (CF) drug, Orkambi, to treat patients aged 12 and ... Bidness Etc, 17 hours ago

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From the FDA, one still hears mostly thunderous silence

This article provides a valuable but rare peek behind the FDA's iron curtain. The discussion section begins, "our analysis found that the FDA's reasons for not approving marketing applications for new molecular entities are not being fully conveyed ...
 British Medical Journal12 hours ago
Tech Times

Theranos Blood Test For Herpes Approved By The FDA

The FDA has approved use of the finger-prick blood test kit for herpes developed by startup company Theranos. Despite criticism, the company founder said the decision of the FDA validates Theranos' commitment to providing affordable and high-quality ...
 Tech Times2 hours ago Theranos blood test: The insanely influential Stanford professor behind the firm's push to get FDA approval it (probably) doesn't need  Washington Post1 day ago FDA approves Theranos $9 finger stick blood test for herpes  Washington Post2 days ago Wonkblog: FDA approves Theranos $9 finger stick blood test for herpes  Washington Post2 days ago
Pharmaceutical Business Review

Pfizer's NDA for once-daily XELJANZ modified release tablets to be reviewed by the US FDA for rheumatoid arthritis

Healthcare company Pfizer The company added that the US FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016 for the NDA for XELJANZ (tofacitinib citrate) 11 mg once daily modified release tablets for ...
 Bloomberg1 day ago FDA accepts to review Pfizer's NDA for rheumatoid arthritis drug Xeljanz  Pharmaceutical Business Review1 day ago Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ® (tofacitinib citrate) Modified Release Tablets  Nasdaq2 days ago US FDA accepts Juno's IND application for JCAR017 to treat relapsed/refractory B cell NHL  PharmaBiz3 days ago

CereSpir seeks US FDA approval to begin phase 3 study of CSP-1103 to treat mild cognitive impairment due to AD

CereSpir Incorporated, a company with a novel approach to treat neurodegenerative diseases by harnessing the innate immune system, has submitted a Special Protocol Assessment (SPA) request to the US Food and Drug Administration (FDA) to initiate ...
 PharmaBiz1 day ago CereSpir Incorporated Submits Special Protocol Assessment Request to FDA for a Phase 3 Clinical Trial to Test the Ability of CSP-1103 to Slow the Progression of Mild Cognitive Impairment Due to Alzhei  Pettinga Financial Advisors3 days ago

Addivant Receives Further FDA Approvals for the Use of Its Next Generation Weston® 705 Liquid Phosphite Antioxidant for Food Contact Applications

DANBURY, Conn -- Addivant , a global leader in polymer additive technologies, announced that its WESTON® 705 phosphite antioxidant for use in polymers, has received additional food contact clearance from the U.S. Food and Drug Administration (FDA) ...
 SpecialChem Polymer Additives1 day ago

Vanda lists new HETLIOZ patent (995 patent) in the US FDA Orange Book

Biopharmaceutical company Vanda Pharmaceuticals (Nasdaq GM:VNDA) disclosed on Thursday that the HETLIOZ patent is now listed in the US FDA Orange Book. According to the company, the HETLIOZ patent, which has been assigned the number 9,060,995 ('995 ...
 Bloomberg1 day ago Vanda lists new HETLIOZ patent ('995 patent) in the US FDA Orange Book  Individual.com1 day ago
Money Control

Medicines Company receives FDA approval for new PCI therapy

The Medicines Company, a biopharmaceutical company, has received the FDA approval for KENGREAL, or cangrelor, as an adjunctive therapy to percutaneous coronary intervention, or PCI, for reducing periprocedural thrombotic events in patients who have ...
 Individual.com2 days ago Medtronic receives FDA approval for MRI single-chamber pacemaker  Individual.com2 days ago MEDICINES : Announces FDA Approval of KENGREAL cangrelor as an Adjunct to Percutaneous Coronary Intervention PCI for Reducing Thrombotic...  4 Traders3 days ago US FDA approves sale of Strides Arcolab's HIV treatment drug  Business Standard1 month ago

FDA to investigate use of codeine in kids

iStock As the European Medicines Agency (EMA) withdraws its support of the use of codeine in children under the age of 12, the U.S. Food and Drug Administration, said that it will also look into the matter, reports NBC News . "We have looked ...
 UnitedHealthcare2 days ago FDA Investigating Possible Risks Of Codeine In Cough Medicine For Children  Tech Times1 day ago FDA Reviewing Safety of Codeine for Cough in Kids Under 18  General Medicine eJournal3 days ago FDA evaluating the potential risks of using codeine cough-and-cold medicines in children  FirstWord Pharma3 days ago
Reuters India

Leveraging the FDA's proposed food label changes

What does the FDA's revision of the Nutrition and Supplement Facts Labels mean for your brand and package design? SGK's Carol Best shares her views and advice. Carol Best, VP, Client Engagement, SGK, presents on the topic Turning FDA Proposed ...
 Packaging Digest2 days ago FDA moving to regulate e-cigarettes, vaping liquid nicotine  ArsTechnica1 day ago FDA seeks data on e-cigarettes after surge in poisoning cases  CNBC4 days ago FDA Considers Warning for e-Cigarettes, Liquid Nicotine  P&T Community3 days ago
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