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About 1015 results for "us food drug administration"

Clovis's ovarian cancer drug wins accelerated FDA approval
Reuters

Panacea Biotec Limited

on Wednesday said the US Food and Drug Administration has approved the companys abbreviated new drug application for rizatritan benzoate orally disintegrating tablets of 5 mg and 10 mg strengths, which is the generic equivalent of Maxalt-MLT marketed by Merck ... Business Line, 1 hour ago
JUVÉDERM VOLBELLA XC... MedEsthetics Magazine, 22 hours ago
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1,290 images for us food drug administration

PharmaVOICE, 1 week ago
Reuters India, 17 hours ago
4 Traders, 18 hours ago
PharmaVOICE, 1 month ago
Houston Chronicle, 1 week ago
Pharma Focus Asia, 3 weeks ago
National Hog Farmer, 2 weeks ago
NBCNews.com, 1 month ago
NBCNews.com, 1 month ago
Reuters UK, 4 weeks ago
MedEsthetics Magazine

FDA: New Potential Infection Risk With Pentax Duodenoscope

The US Food and Drug Administration (FDA) has issued an updated safety communication on the ED-3490TK video duodenoscope from Pentax regarding a design problem that could increase the risk for patient infection. "Cracks and gaps in the adhesive ...
 Dermatology Online Journal32 minutes ago FDA Calls for More...  MedEsthetics Magazine1 day ago FDA Developing Requirements For Evaluation Of Tech-Enabled Clinical Algorithms  Open Minds.com2 days ago
BioSpace

Tarix Orphan Release: Company Receives Rare Pediatric Disease Designation For TXA127 For Recessive Dystrophic Epidermolysis Bullosa (RDEB)

CAMBRIDGE, Mass. , Jan. 18, 2017 /PRNewswire/ --Tarix Orphan LLC today announced that the U.S. Food and Drug Administration has granted a Rare Pediatric Disease (RPD) designation for the company's drug candidate TXA127 for the treatment of Recessive ...
 BioSpace27 minutes ago Tarix Orphan Receives Rare Pediatric Disease Designation for TXA127 for Recessive Dystrophic Epidermolysis Bullosa (RDEB)  PR Newswire3 hours ago Lysogene Receives Rare Pediatric Disease Designation from FDA for LYS-GM101 for Treatment of GM1 Gangliosidosis  Business Wire4 hours ago Lysogene Release: Biotech Receives Rare Pediatric Disease Designation From FDA For LYS-GM101 For Treatment Of GM1 Gangliosidosis  BioSpace1 hour ago
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Humanosphere

BRIEF-U.S. FDA approves a generic of Xyrem with a REMS program

n"Jan 17 U.S. Food and Drug Administration : * FDA approves a generic of Xyrem with a REMS program Source text -
 Reuters UK18 hours ago FDA approves generic version of Jazz Pharma's sleep disorder drug  Sharenet18 hours ago FDA decision may make Chagas treatment even more expensive  Humanosphere19 hours ago FDA is making progress inspecting foreign drug plants, but could do better  StatNews.com19 hours ago
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LymphomaNewsToday.com

FDA Orphan Drug Designation Granted to Profounda Inc. for the treatment of Acanthamoeba Keratitis with miltefosine

Share ORLANDO, Fla. , - Profounda, Inc. ("Profounda") announced that it has received the US Food and Drug Administration's (FDA) Orphan Drug Designation for the treatment of Acanthamoeba Keratitis with miltefosine.Profounda licensed miltefosine ...
 Tampa Bay Medical News7 hours ago Combo Therapy for CLL, Now in Phase 3 Study, Named Orphan Drug by FDA  LymphomaNewsToday.com1 day ago Hunting For Pharma Deals, Ovid Bags Epilepsy Drug from Takeda  Xconomy4 hours ago ADALTA : receives Orphan Designation for its lead drug candidate targeting patients with idiopathic pulmonary disease  4 Traders7 hours ago
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New FDA Chief Should Have Medical Experience, Drugmakers Say

President-elect Donald Trump's pick to lead the U.S. Food and Drug Administration should have a medical background, and the agency should continue evaluating new medications effectiveness, drugmaker executives said in comments indicating opposition ...
 Bloomberg20 hours ago
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4 Traders

U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily ...
 CPhI.cn2 days ago Allergan moves toward NDA after uterine fibroid drug's success  BioPharma Dive23 hours ago FDA delays decision on Lilly and Incyte's arthritis drug  BioPharma Dive23 hours ago US FDA extends review period for Eli Lilly and Incyte's rheumatoid arthritis treatment  Pharmaceutical Technology2 days ago
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BRIEF-Spineguard gets FDA clearance for its dynamic surgical guidance integration module

n"Jan 16 Spineguard Sa * Has received 510(k) clearance from U.S. Food and Drug Administration (FDA) for its new dynamic surgical guidance integration module to be used in combination with Zavation's spinal fusion system to make its pedicle screws ...
 Reuters UK1 day ago SpineGuard secures FDA 510(k) clearance for DSG integration module to make pedicle screw smart Jan 17  Medical Device Network1 day ago MindChild Medical, Inc. Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration (FDA) for the MERIDIAN M110 Fetal Monitoring System  Minyanville1 day ago FDA approves SpineGuard's DSG integration module to make pedicle screws smart  Medical Devices Business Review1 day ago
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India-West

Indian American could be FDA head under Trump

Indian-American biotech entrepreneur Balaji Srinivasan is being considered for a role in the U.S. Food and Drug Administration (FDA) under President Donald Trump, the transition team said. Mr. Srinivasan, who is currently CEO and co-founder of ...
 The Hindu1 day ago Indian American Founder of Bitcoin Startup May Be Up for Food and Drug Administration Post  India-West1 day ago Indian American Ajit Pai could be chairman of Federal Communications Commission  The American Bazaar1 hour ago Indian Americans a growing political force: Forbes  The American Bazaar1 hour ago
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Incyte PDUFA Date Pushed Back, JMP Discusses Impact

There has been a three-month delay in the Food and Drug Administration Prescription Drug User Fee Act date for Incyte Corporation (NASDAQ: INCY )'s partnered rheumatoid arthritis drug, baricitinib. The U.S. approval and launch of the drug is now ...
 Benzinga.com1 day ago
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