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About 1332 results for "fda"

FDA Approves Vasopressin Injection to Treat Vasogenic Shock

—Vasostrict, from Par Sterile Products LLC, on Thursday became the first vasopressin injection product whose labeling has been approved by FDA, according to information at the agency's website. FDA's letter to the company states that the ... ASHP, 16 minutes ago

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Allergy Pills Newly Approved by FDA Could Provide Relief

Allergy pills that really work, are highly sought after by those with seasonal allergies, and the Food and Drug Administration (FDA) is trying to provide relief for sufferers with some newly approved drugs. Oralair, Grastek, and Ragwitek are the ...
 The Guardian Express38 minutes ago New drug for the treatment of ragweed pollen allergies  Examiner.com2 hours ago FDA Approves Under-the-Tongue Hay Fever Pill-April 17, 2014  InteliHealth1 day ago FDA approves Paladin drug to treat tropical disease  Reuters4 weeks ago

High-Risk Pediatric Devices Seldom Tested in Children

Most high-risk medical devices that have been cleared by the US Food and Drug Administration (FDA) for pediatric use have not been tested in patients younger than 18 years, according to a study published online April 14 in Pediatrics . The ...
 Medscape6 hours ago FDA Discourages Laparoscopic Power Morcellation Method For Removal Of Uterus  RTTNews.com20 hours ago FDA discourages certain procedure to treat uterine fibroids  Nurse.com6 hours ago FDA Warns Against Morcellation in Hysterectomy  Diabetes Care1 day ago
Pharmaceutical Technology

FDA Approves Sublingual Ragweed Immunotherapy

—Just in time for the ragweed pollen season, FDA on Thursday approved the short ragweed pollen allergen extract tablet for sublingual use by adults 1865 years of age with a test-confirmed allergy to the pollen. The biological, by Merck & Co.
 ASHP9 hours ago Merck receives FDA approval for ragweed pollen-induced allergic rhinitis drug  Individual.com15 hours ago FDA OKs Ragwitek Hay Fever Tablet  MedPage Today15 hours ago FDA Grants Approval to Merck's Grastek (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults  Individual.com2 days ago

Baxano Surgical receives FDA clearance for pedicle screw system

Baxano Surgical, Inc., a medical device company, has received the FDA 510(k) clearance for its Avance MIS pedicle screw system, which may be used as an adjunct to fusion in degenerative and complex spinal pathologies. The innovative design of Avance ...
 Individual.com19 hours ago Syneron Medical's CEO Discusses FDA Clearance of the UltraShape System - Conference Call Transcript  Seeking Alpha1 day ago St. Jude Medical receives FDA approval for pain management system  Individual.com1 day ago FzioMed Receives FDA Notification on Oxiplex Gel Decision Date  Individual.com2 days ago

GSK and Genmab's sBLA for CLL drug receives FDA approval

GlaxoSmithKline plc, or GSK, and Genmab A/S have received FDA approval for a supplemental biologic license application, or sBLA, for Arzerra, a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously ...
 Individual.com15 hours ago GSK, Genmab Get FDA Approval For Arzerra As First-Line Treatment For CLL  RTTNews.com1 day ago FDA expands use of GlaxoSmithKline, Genmab's Arzerra to include first-line treatment of CLL  FirstWord Pharma13 hours ago Genmab A/S : GSK and Genmab Receive FDA Approval for Arzerra® (ofatumumab) as First-Line Treatment in Combination with Chlorambucil for Patients with Chronic Lymphocytic Leukemia (CLL) for Whom Fludarabine-Based Therapy is Considered Inappropriate  4 Traders1 day ago
Medical Devices Business Review

FDA Clears Breathe Tech's NIOV System For Respiratory Insufficiency

By Estel Grace Masangkay Breathe Technologies announced that the U.S. Food and Drug Administration (FDA) has granted 501(k) clearance for its Non-Invasive Open Ventilation (NIOV) System for use with compressed air supply. The latest clearance ...
 Pharmaceutical Online1 day ago Breathe Technologies obtains fifth FDA approval for NIOV system  Medical Devices Business Review21 hours ago FDA grants clearance for Breathe Technologies Non-Invasive Open Ventilation System  News-Medical.Net1 day ago Breathe Technologies, Inc. Announces FDA Clearance For NIOV System For Use With Compressed Gas  TickerTech.com1 day ago

Lawmakers urge FDA to modify brewery grain rules

Lawmakers are pushing the Food and Drug Administration to modify proposed rules requiring breweries to inspect spent grain given to cattle. In a letter to FDA Commissioner Margaret Hamburg, 13 House members said the proposed regulation would ...
 The Hill8 hours ago FDA's Proposed Regulation Of Brewers' Spent Grains Is All Wet  Forbes.com1 day ago

Surround Sound: USFDA's 'to do' list to ensure data integrity

Among the various warning letters that the US Food and Drug Administration (FDA) issued to companies found wanting in terms of meeting the regulatory compliance requirements, there was one that may be worth looking at closely. It is the February 6, ...
 InToday7 hours ago FDA issues warning to manufacturer of supplement containing meth-like substance  FOXNews.com2 days ago Cats should be shielded from lilies, FDA warns  Examiner.com2 days ago FDA Issues Easter Lilies Warning to Cat Owners  InvestorPlace.com3 days ago

FDA Clears New Heart Pacing Devices

 Diabetes Care11 hours ago US FDA ok's new generation heart pacing devices days ago U.S. FDA OKs new generation Boston Scientific heart pacing devices  AlertNet3 days ago FDA OKs new generation Boston Scientific heart pacing devices  Reuters3 days ago
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