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About 1066 results for "us fda"

J&J leukaemia drug gets FDA go-ahead
Pharmafocus

JOHNSON & JOHNSON : Former FDA chief calls J&J misleading on R...

Jan. 31 --Former U.S. Food and Drug Administration Commissioner David Kessler said Friday in Philadelphia that Johnson & Johnson officials were "at best" misleading when they told the FDA in 2005 that there was no correlation between the drug ... 4 Traders, 10 hours ago
J&J leukaemia drug gets FDA go-ahead Pharmafocus, 1 day ago
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147 images for us fda

PRLog, 1 day ago
India TV, 4 days ago
Bio Spectrum Asia, 1 day ago
Proactive Investors USA, 1 day ago
India TV, 23 hours ago
Popsci.com.au, 1 week ago
Examiner.com, 2 weeks ago
Proactive Investors.co.uk, 1 week ago
Pharma Letter, 4 days ago
PRWeb, 2 weeks ago
Ecancer Medicalscience

Darunavir/Cobicistat (Prezcobix) Combo Pill Clears FDA

The US Food and Drug Administration (FDA) has approved a fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) for HIV treatment. Prezcobix , from Janssen Therapeutics, is ...
 General Medicine eJournal1 day ago Bristol-Myers Squibb Co (BMY) HIV-1 Combo Drug Gets FDA Nod  Bidness Etc1 day ago Shire announces FDA approval of Vyvanse Capsules for binge eating disorder  News-Medical.Net22 hours ago FDA expands uses of Vyvanse to treat binge-eating disorder  FirstWord Pharma1 day ago
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Diagnostic & Invasive Cardiology

St. Jude Medical's New Ablation Catheter Receives FDA Approval

By Suzanne Hodsden Catheter ablation, a clinical technique for treating cardiac arrhythmias, has a brand new tool at its disposal. The Food and Drug Administration (FDA) recently approved St. Jude Medical's FlexAbility ablation catheter for ...
 Medical Design Online11 hours ago St. Jude Medical Updates on FDA Approval of FlexAbility Ablation Catheter  Individual.com1 day ago FDA gives thumbs up to flex-tipped ablation catheter  Cardiovascular Business2 days ago St. Jude Medical Announces FDA Approval of FlexAbility Ablation Catheter  Diagnostic & Invasive Cardiology2 days ago
Medical Design Online

FDA Releases cGMP Draft Guidance For Combination Products

By Estel Grace Masangkay The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements ...
 Medical Design Online11 hours ago FDA releases 53 new and revised bioequivalence guidelines for generics  GaBi Online1 day ago FDA Policy On Wellness Products Is Healthy For Industry  JD Supra2 days ago

Role of US FDA likely to witness a sea change

The role of the US FDA may change from that of mere an "investigator" to that of an "enabler" bringing in attitudinal and culture change and transform product quality oversight from a qualitative (subjective) to a quantitative (objective) and ...
 PharmaBiz15 hours ago

US FDA approves Prezcobix to treat adults living with HIV-1

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), announced the US Food and Drug Administration (FDA) has approved Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor, ...
 PharmaBiz16 hours ago Janssen's PREZCOBIX gets FDA approval to treat adults living with HIV-1  Pharmaceutical Business Review1 day ago FDA Approves Prezcobix (darunavir and cobicistat) for HIV-1 Infection in Adults  Drugs.com1 day ago 1/30/15 - Janssen's PREZCOBIX gets FDA approval to treat adults living with HIV-1 [EMBIN (Emerging Markets Business Information News]  Pharmacy Choice18 hours ago

MagForce and MagForce USA Hold Pre-IDE Meeting with FDA

MagForce, together with its subsidiary MagForce USA, reported that an in-person meeting was held with the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health to discuss FDA's response to MagForce's NanoTherm Prostate ...
 Individual.com1 day ago MagForce : and MagForce USA Reports Pre-IDE Meeting with FDA  4 Traders19 hours ago MAGFORCE : and MagForce USA Hold Pre-IDE Meeting with FDA  4 Traders1 day ago

FDA Grants Fast Track Designation for BCX4161 for the Treatment of Hereditary Angioedema

RESEARCH TRIANGLE PARK, N.C., Jan. 26, 2015 -- BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BCX4161, a novel, orally administered, selective ...
 Drugs.com18 hours ago Shire's investigation formulation SHP609 receives US FDA fast track designation to treat Hunter syndrome  PharmaBiz3 days ago BioCryst Pharmaceuticals awarded US FDA's Fast Track designation for BCX4161 for hereditary angioedema  BusinessWeek4 days ago CorMedix awarded US FDA's fast track designation for Neutrolin  BusinessWeek2 weeks ago

FDA reevaluates safety of automated external defibrillators

The FDA recently announced it plans to strengthen its review of automated external defibrillators to help improve the quality and reliability of the devices. According to an agency press release, there have been 111 AED recalls, affecting more ...
 Orthopedics Today9 hours ago US FDA to strengthen its review of AEDs to improve quality & reliability of devices  PharmaBiz2 days ago FDA Issues New Order to Make AEDs More Reliable  Aquatics International2 days ago FDA Takes Steps to Improve Reliability of Automated External Defibrillators  Drugs.com3 days ago

FDA OKs Natpara [Professional Services Close - Up]

NPS Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone) as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. According to a company ...
 Pharmacy Choice11 hours ago 1/30/15 - Symplmed Gets FDA Approval of Prestalia [Professional Services Close - Up]  Pharmacy Choice1 day ago Symplmed and Servier receive FDA approval for hypertension drug  Individual.com2 days ago NPS PHARMACEUTICALS : FDA OKs Natpara  4 Traders2 days ago
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