Food and Drug Administration (FDA)
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Service Smoked Fish Corp. Recalls Smoked Nova Salmon Because of Possible Health Risk
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Service Smoked Fish Corp. of Brooklyn, NY, is recalling specific “Use-By” dates and lot codes of Brooklyn’s BEST brand SMOKED NOVA SALMON because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may possibly suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. (Source: Food a...
Source: Food and Drug Administration - November 20, 2009 Category: Food Science Source Type: organizations
Fresh & Easy Neighborhood Market Issues Allergy Alert on Undeclared Pecans in Mislabeled Fresh & Easy Pumpkin Cheesecake Pies
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– Fresh & Easy Neighborhood Market is voluntarily recalling some fresh&easy™ “Pumpkin Cheesecake Pies” (40 oz.) because they may contain undeclared pecans. Individuals who have allergies to pecans run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 20, 2009 Category: Food Science Source Type: organizations
FDA Takes Action Against Maryland Veal Calf Dealer
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The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. The complaint, filed Nov. 13, 2009, in the U.S. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: Litigation / Medical Malpractice Source Type: news
FDA Issues 22 Warning Letters To Web Site Operators
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The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products. (Source: IT / Internet / E-mail News From Medical News Today)
Source: IT / Internet / E-mail News From Medical News Today - November 20, 2009 Category: Information Technology Tags: IT / Internet / E-mail Source Type: news
FDA Issues 22 Warning Letters To Web Site Operators
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The U.S. Food and Drug Administration completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: IT / Internet / E-mail Source Type: news
Nigeria: Nation Still Battles to Make Food, Drugs Safe - NAFDAC Boss
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THE Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) Dr. Paul Orhii, has said Nigeria is still grappling with the challenge to make safe qualitative, affordable food and medicines available to the people. (Source: AllAfrica News: Health and Medicine)
Source: AllAfrica News: Health and Medicine - November 20, 2009 Category: African Health Source Type: news
Pew Health Group Statement On Senate Mark Up Of The FDA Food Safety Modernization Act (S. 510)
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Sandra Eskin, director of the Pew Health Group's Food Safety Campaign, has issued the following statement regarding the markup of the FDA Food Safety Modernization Act by the Senate Health, Education, Labor, & Pensions Committee: "The Pew Health Group applauds the members of the Senate Health, Education, Labor, & Pensions (HELP) Committee for approving the FDA Food Safety Modernization Act (S. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: Nutrition / Diet Source Type: news
Pew Health Group Statement On Senate Mark Up Of The FDA Food Safety Modernization Act (S. 510)
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Sandra Eskin, director of the Pew Health Group's Food Safety Campaign, has issued the following statement regarding the markup of the FDA Food Safety Modernization Act by the Senate Health, Education, Labor, & Pensions Committee: "The Pew Health Group applauds the members of the Senate Health, Education, Labor, & Pensions (HELP) Committee for approving the FDA Food Safety Modernization Act (S. 510) today. (Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today)
Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today - November 20, 2009 Category: Infectious Diseases Tags: Nutrition / Diet Source Type: news
Aspirin kills 400% more people than H1N1 swine flu
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(NaturalNews) The CDC now reports that nearly 4,000 Americans have been killed by H1N1 swine flu. This number is supposed to sound big and scary, motivating millions of people to go out and pay good money to be injected with untested, unproven H1N1 vaccines. But let's put the number in perspective: Did you know that more than four times as many people are killed each year by common NSAID painkillers like aspirin?The July 1998 issue of The American Journal of Medicine explains it as follows:"Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory dr...
Source: NaturalNews.com - November 20, 2009 Category: Consumer Health Advice Source Type: news
Analysis of couch position tolerance limits to detect mistakes in patient setup.
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This work investigates the use of the tolerance limits on the treatment couch position to detect mistakes in patient positioning and warn users of possible treatment errors. Computer controlled radiotherapy systems use the position of the treatment couch as a surrogate for patient position and a tolerance limit is applied against a planned position. When the couch is out of tolerance a warning is sent to a user to indicate a possible mistake in setup. A tight tolerance may catch all positioning mistakes while as the same time sending too many warnings; while a loose tolerance will not catch all mistakes. We develop a s...
Source: Journal of Applied Clinical Medical Physics - November 20, 2009 Category: Physics Authors: Hadley SW, Lam KL, Balter JM Tags: J Appl Clin Med Phys Source Type: journals
Spineology Receives FDA Clearance For Capture™ Facet Screw System
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Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. The Capture System was developed by Spineology in mid-2009 under the direction of Dr. Chet Sutterlin, product development consultant. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: Neurology / Neuroscience Source Type: news
Spineology Receives FDA Clearance For Capture™ Facet Screw System
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Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. The Capture System was developed by Spineology in mid-2009 under the direction of Dr. Chet Sutterlin, product development consultant. (Source: Neurology / Neuroscience News From Medical News Today)
Source: Neurology / Neuroscience News From Medical News Today - November 20, 2009 Category: Neuroscience Tags: Neurology / Neuroscience Source Type: news
Update: Peramivir IV Fact Sheet for Health Care Providers (PDF)
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Revised documents to reflect new peramivir IV renal dosing and administration recommendations, authorized by FDA on November 19, 2009. (Source: CDC Swine Flu Updates)
Source: CDC Swine Flu Updates - November 20, 2009 Category: Infectious Diseases Source Type: organizations
Update: FDA-Issued Peramivir IV EUA Letter (PDF)
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Revised documents to reflect new peramivir IV renal dosing and administration recommendations, authorized by FDA on November 19, 2009. (Source: CDC Swine Flu Updates)
Source: CDC Swine Flu Updates - November 20, 2009 Category: Infectious Diseases Source Type: organizations
Arizona Medtech Company's Technology Breakthrough The First To Achieve FDA Approval For See/Treat Ultrasound
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Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU). (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: MRI / PET / Ultrasound Source Type: news
Arizona Medtech Company's Technology Breakthrough The First To Achieve FDA Approval For See/Treat Ultrasound
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Guided Therapy Systems, LLC (GTS), a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound (ITU). Addressing a $4 billion market, the company's patented products combine ultrasound imaging with ultrasound treatment in a single non-invasive "see and treat" device. The "see" capability allows physicians to see into the body without surgery. (Source: MRI / PET / Ultrasound News From Medical News Today)
Source: MRI / PET / Ultrasound News From Medical News Today - November 20, 2009 Category: Radiology Tags: MRI / PET / Ultrasound Source Type: news
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
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Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: Lymphoma / Leukemia / Myeloma Source Type: news
Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
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Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL). (Source: Cancer / Oncology News From Medical News Today)
Source: Cancer / Oncology News From Medical News Today - November 20, 2009 Category: Cancer & Oncology Tags: Lymphoma / Leukemia / Myeloma Source Type: news
FDA Advisory Committee Finds Data Support The Safety And Effectiveness Of Prevnar 13™ Vaccine For The Prevention Of Invasive Pneumococcal Diseas
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Pfizer Inc (NYSE:PFE) announced today that the U.S. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 20, 2009 Category: Consumer Health News Tags: Immune System / Vaccines Source Type: news
FDA Advisory Committee Finds Data Support The Safety And Effectiveness Of Prevnar 13™ Vaccine For The Prevention Of Invasive Pneumococcal Diseas
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Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. (Source: Immune System / Vaccines News From Medical News Today)
Source: Immune System / Vaccines News From Medical News Today - November 20, 2009 Category: Allergy & Immunology Tags: Immune System / Vaccines Source Type: news
Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
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Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use. (Source: FDA MedWatch)
Source: FDA MedWatch - November 20, 2009 Category: American Health Source Type: organizations
Vicks Sinex Nasal Spray - Recall
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Product found containing the bacteria B. cepacia. (Source: FDA MedWatch)
Source: FDA MedWatch - November 20, 2009 Category: American Health Source Type: organizations
[Comment] β2-receptor polymorphisms in asthma
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In The Lancet today, Michael Wechsler and colleagues, from the Asthma Clinical Research Network (ACRN) of the US National Heart, Lung, and Blood Institute, report the LARGE study of the effects of a single-nucleotide polymorphism of the β2-adrenergic receptor on the addition of the longacting inhaled β2 agonist, salmeterol, to inhaled corticosteroid therapy. These investigators found significant improvements in baseline lung function as measured by morning peak expiratory flow with no genotype difference. They concluded that their data supported the current guideline recommendations for the use of these agonists in conju...
Source: LANCET - November 20, 2009 Category: Journals (General) Authors: H William Kelly Tags: Comment Source Type: journals
FDA Advisory Committee Finds Data Support SPIRIVA® HandiHaler®
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The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a supplemental new drug application (sNDA) provide substantial and convincing evidence to support the claim that SPIRIVA® HandiHaler® (tiotropium bromide inhalation powder) reduces exacerbations (worsening of symptoms) in patients with chronic obstructive pulmonary disease (COPD). (Source: World Pharma News)
Source: World Pharma News - November 20, 2009 Category: Pharmaceuticals Source Type: news
First human trials for stem cell blindness therapy
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The first human trials of a stem cell therapy for an eye disease that causes blindness in young people could start next year. (Source: Telegraph Health)
Source: Telegraph Health - November 19, 2009 Category: Consumer Health News Tags: blindness human trials stem cell FDA Source Type: news
FDA Panel Rejects Cell Culture Flu Vaccine, Wants More Safety Data
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BETHESDA, Md. (MedPage Today) -- With members citing unanswered safety questions, an FDA advisory panel today narrowly rejected approval of the nation's first cell-based influenza vaccine -- an alternative to vaccines produced by the traditional, time-consuming method of growing the virus in eggs. (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - November 19, 2009 Category: Geriatrics Source Type: news
P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom
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The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: Food Science Source Type: organizations
FDA Takes Action Against Maryland Veal Calf Dealer
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The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: American Health Source Type: organizations
FDA Panel Backs Safety, Benefits of Spiriva
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From Associated Press (November 19, 2009)
WASHINGTON-Federal health experts on Thursday brushed off
lingering safety questions about a popular inhaler drug and
suggested it carry bolder benefit claims.
The Food and Drug Administration's panel of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2009 Category: Pharmaceuticals Source Type: news
FDA panel votes against new bug-based flu vaccine
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BETHESDA, Maryland (Reuters) - More safety data would be needed before a new type of influenza vaccine made in insect cells should get approval, federal advisers said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - November 19, 2009 Category: Consumer Health News Tags: healthNews Source Type: news
More influenza vaccine FDA-approved for use in children [News and Features]
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(Source: AAP News)
Source: AAP News - November 19, 2009 Category: Pediatrics Tags: News and Features Source Type: journals
New: Updated Guidance for the Use of CSL 2009 H1N1 Monovalent Vaccine
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On November 11, 2009, the FDA expanded the approved use of CSL’s™ seasonal and 2009 H1N1 monovalent influenza vaccines to include children aged 6 months and older. Both vaccines had previously been approved only for use in adults, aged 18 years and older. (Source: CDC Swine Flu Updates)
Source: CDC Swine Flu Updates - November 19, 2009 Category: Infectious Diseases Source Type: organizations
False positive on breast cancer | Sarah Wildman
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A panel's recommendation that American women need fewer mammograms would mean more deaths from breast cancerIn the US we've heard the refrain for two decades: early detection saves lives. But this week a federal advisory board decided that while that slogan wasn't false, in the case of breast cancer, it just wasn't true enough. After years of pink ribbons and breast cancer marches and admonishments to examine our breasts, this week the US Preventative Services Task Force bucked conventional wisdom (and the American Cancer Society) claiming that the number of women saved by early detection through mammography was not enough...
Source: Guardian Unlimited Science - November 19, 2009 Category: Science Authors: Sarah Wildman Tags: US healthcare Women Healthcare industry Cancer Obama Administration & wellbeing United States World news guardian.co.uk Comment Comment is free Source Type: news
FDA: GE, Bayer, Covidien MR agents carry highest risk
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After years of research regarding gadolinium-based contrast agents used during MRI being linked to the skin disease nephrogenic systemic fibrosis (NSF), the FDA has found the greatest risk in GE Healthcare’s Omniscan, Bayer HealthCare's Magnevist and Covidien’s Optimark. (Source: Health Imaging News)
Source: Health Imaging News - November 19, 2009 Category: Radiology Tags: Latest News Source Type: news
FDA Issues 22 Warning Letters to Web Site Operators
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(Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - November 19, 2009 Category: Pharmaceuticals Authors: Pharma Manufacturing Source Type: info
FDA Issues 22 Warning Letters to Web Site Operators
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Part of International Internet Week of Action
SILVER SPRING, Md., Nov. 19 /PRNewswire-USNewswire/ --The U.S.
Food and Drug Administration today completed a coordinated,
weeklong, international effort, called the International Internet
Week of... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2009 Category: Pharmaceuticals Source Type: news
Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared Allergens on their Tasty Dish Snack Tubs of Chocolate Almonds, Chocolate Raisins and Sour Neon Worms
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Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts, cashews and coconut}. People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products... (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: Food Science Source Type: organizations
FDA Panel Recommends Prevnar 13 Vaccine for Approval
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An advisory committee voted 10 to 1 (with 1 abstention) to approve Pfizer's request for licensure of Prevnar 13 to immunize infants and children against invasive pneumococcal disease. (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 19, 2009 Category: Consumer Health News Tags: Infectious Diseases Source Type: news
FDA Panel Considers New Cell-Based Flu Vaccine
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BETHESDA, Md. (MedPage Today) -- A Food and Drug Administration (FDA) panel is considering approval of the nation's first cell-based influenza vaccine -- an alternative to vaccines produced by the traditional, time-consuming method of growing the virus in eggs. (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - November 19, 2009 Category: Geriatrics Source Type: news
FDA Issues 22 Warning Letters to Web site Operators
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The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: American Health Source Type: organizations
FDA Panel Backs Pfizer's Enhanced Vaccine for Kids
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From Associated Press (November 19, 2009)
BETHESDA, Md.--Federal health experts said Wednesday an updated
version of Pfizer's best-selling anti-infection vaccine is safe and
effective for infants and toddlers, despite company studies that
failed to... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2009 Category: Pharmaceuticals Source Type: news
AstraZeneca Submits US New Drug Application for ticagrelor (Brilinta), an Investigational Antiplatelet Agent
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WILMINGTON, Del., Nov. 19 /PRNewswire-FirstCall/ -- AstraZeneca
today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for ticagrelor, an investigational oral antiplatelet
treatment for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 19, 2009 Category: Drugs & Pharmacology Source Type: news
FDA panel backs stronger benefit claims and safety profile for inhaler drug Spiriva
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WASHINGTON (AP) — Federal health experts on Thursday brushed off lingering safety questions about a popular inhaler drug and suggested it carry bolder benefit claims.
The Food and Drug Administration's panel of lung specialists voted 11-1 in... (Source: OrlandoSentinel: Medical Research)
Source: OrlandoSentinel: Medical Research - November 19, 2009 Category: American Health Source Type: news
AstraZeneca Submits US New Drug Application for Ticagrelor (BRILINTA(TM)), an Investigational Antiplatelet Agent
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WILMINGTON, Del., Nov. 19 (HSMN NewsFeed) -- AstraZeneca (NYSE: AZN ) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the redu... Biopharmaceuticals, CardiologyAstraZeneca, ticagrelor, BRILINTA, acute coronary syndrome, PLATO (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 19, 2009 Category: Pharmaceuticals Source Type: news
FDA Approves New Treatment for Shingles-Related Pain
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(Source: Physician's First Watch current issue)
Source: Physician's First Watch current issue - November 19, 2009 Category: Primary Care Tags: Medical News Source Type: info
Genentech, Biogen Get FDA Request on Rituxan
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From Associated Press (November 18, 2009)
NEW YORK--Genentech Inc. and partner Biogen Idec Inc. said
Wednesday the Food and Drug Administration is withholding a
decision to expand approval of Rituxan as a leukemia treatment,
pending further... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 19, 2009 Category: Pharmaceuticals Source Type: news
FDA Takes Action Against Dairy Farm And Owner
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On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 19, 2009 Category: Consumer Health News Tags: Water - Air Quality / Agriculture Source Type: news
FDA Announces New Warning On Plavix: Avoid Use With Prilosec/Prilosec OTC
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Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. New data suggest that when patients take both Prilosec and Plavix, Plavix's ability to block platelet aggregation (anti-clotting effect) may be reduced by about half. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 19, 2009 Category: Consumer Health News Tags: Blood / Hematology Source Type: news
FDA Takes Action Against Dairy Farm And Owner
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On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs. (Source: Water Quality / Air Quality News From Medical News Today)
Source: Water Quality / Air Quality News From Medical News Today - November 19, 2009 Category: Nutrition Tags: Water - Air Quality / Agriculture Source Type: news
