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About 1117 results for "fda"

Halozyme Gets FDA OK For 2 New Production Sites For Hylenex

By Estel Grace Masangkay Biopharmaceutical company Halozyme Therapeutics announced that it has received the approval of the U.S. Food and Drug Administration (FDA) for its new contract manufacturing facilities that will be used to produce ... Bioresearch Online, 2 hours ago

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U.S. Food and Drug Administration, 9 hours ago
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KSBW, 9 hours ago
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A.M. Best, 17 hours ago, 1 day ago
MassDevice, 2 days ago, 1 day ago
MassDevice, 1 day ago

FDA accepts Merck and Sanofi's BLA to review paediatric hexavalent vaccine

Merck and Sanofi Pasteur have received approval for review from US Food and Drug Administration (FDA) for investigational paediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB. The FDA accepted the biologics licence application (BLA) for the vaccine, ...
 Pharmaceutical Technology1 day ago FDA to review pediatric hexavalent vaccine  Orthopedics Today2 days ago FDA accepts app for Merck, Sanofi 6-in-1 combo vaccine  FierceVaccines2 days ago FDA Accepts Merck's, Sanofi's BLA For Pediatric Hexavalent Vaccine  Bioresearch Online2 hours ago

Arbor Pharmaceuticals Announces FDA Approval of Sotylize

ATLANTA , Oct. 23, 2014 /PRNewswire/ -- Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Sotylize (sotalol hydrochloride) oral solution. Sotylize is the first and ...
 MoneyShow.com3 hours ago FDA Approves Rectal Foam for Ulcerative Colitis  EndoNurse1 day ago

Eli Lilly/Boehringer's Diabetes Drug Under FDA Review

Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an ...
 Zacks.com2 hours ago

Elasto Proxy Announces Custom-Fabricated Rubber Products Made of FDA Approved Silicone Sponge Rubber; Applications Include Food and Pharma

Elasto Proxy , global supplier of specialty seals and custom insulation, is announcing custom-fabricated rubber products made from FDA-approved silicone sponge. By converting sheets, rolls, and extrusions into specialty seals and custom insulation, ...
 MoneyShow.com10 hours ago
Securities Technology Monitor

Auxilium's sBLA for treatment of Dupuytren's contracture receives FDA approval

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, has received the FDA approval for supplemental biologics application, or sBLA, for XIAFLEX for the treatment of up to two Dupuytren's contracture, or DC, joints in the same hand ...
 Individual.com16 hours ago Roth Capital 'Encouraged' by Cytori (CYTX) Receiving FDA Approval to Continue ATHENA  Wall Street Business Network3 hours ago Genzyme receives FDA approval for label update of multiple sclerosis drug  Individual.com1 day ago Trinity Biotech (TRIB) Temporarily Suspends FDA Trials for Meritas Troponin Test  Industrial Info Financials8 hours ago
Jutia Group

Vertex Rises As FDA Advisory Panel Approves Kalydeco's Label Expansion

Vertex stock traded up as the company won the FDA advisory panel's approval needed to expand the company's reach in the cystic fibrosis market Page 1 of 2 Click Ticker to See live coverage Vertex Pharmaceuticals Incorporated ( VRTX ) ...
 Bidness Etc1 day ago NOVARTIS : FDA Advisory Committee Recommends Approval of AIN457 (secukinumab) for Patients with Moderate-to-severe Plaque Psoriasis  4 Traders16 hours ago FDA committee unanimously recommends approval of AIN457 for psoriasis treatment  Orthopedics Today23 hours ago FDA panel votes to expand use of Vertex cystic fibrosis drug  Reuters UK2 days ago

Novartis' Secukinumab Receives Favorable FDA Panel Vote

Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these ...
 Yahoo! Finance3 hours ago

World's First Breast Specimen Tomosynthesis System Receives FDA Approval

Kubtec's Mozart with TomoSpec, a breast specimen radiography system with tomosynthesis technology (Photo courtesy of Kubtec Digital X-ray) Please add personal message for the request Please, fill the area above In providing a comprehensive ...
 MedImaging.net3 hours ago 10/23/14 - Kubtec® Announces FDA Approval of World's First Breast Specimen Tomosynthesis System During Breast Cancer Awareness Month  Pharmacy Choice10 hours ago Varian Medical Systems : Tumor segmentation software receives 510k clearance from FDA  4 Traders23 hours ago

FDA Addresses Device Recall vs. Enhancement Question

What's the difference between a medical device recall and medical device enhancement? The U.S. Food and Drug Administration (FDA) has an answer. In a final guidance document released earlier this month, the FDA spells out the difference between ...
 Medical Design Technology4 hours ago FDA investigates 24 potentially lethal IoT medical devices  TheStack.com1 day ago The FDA wants medical device makers to lock down security  Content Sutra2 weeks ago
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