Food and Drug Administration Newswire (Page 4)

Food and Drug Administration Newswire (Page 4)

Comprehensive Real-Time News Feed for Food and Drug Administration. (Page 4)

Results 61 - 80 of 113,458 in Food and Drug Administration

  1. Stopping opioid-dependence epidemic requires new thinking: Guest commentaryRead the original story w/Photo

    Friday Sep 23 | The Daily Breeze

    ... benefits for both pain and function are anticipated to outweigh risks to the patient. And the Food and Drug Administration recently issued new warnings about the dangers of combining opioids with benzodiazepines, which are used to treat conditions ...

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  2. U.S. FDA Approves Labeling Update of REXULTI (brexpiprazole) For...Read the original story w/Photo

    Friday Sep 23 | Freshnews

    Labeling update includes clinical data on use of REXULTI in adult patients with schizophrenia in the maintenance phase of treatment The trial demonstrated a statistically significant longer time to relapse in patients treated with REXULTI compared to placebo-treated patients Otsuka Pharmaceutical Development & Commercialization, Inc. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration approved the labeling update of REXULTIA to reflect clinical data for maintenance treatment of schizophrenia. The approval was based on results from a long-term randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years.

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  3. BIO Applauds Senate Passage of Advancing Hope ActRead the original story w/Photo

    Friday Sep 23 | Freshnews

    Biotechnology Innovation Organization President and CEO Jim Greenwood released the following statement today regarding Senate passage of the Advancing Hope Act of 2016: "BIO applauds yesterday's action by the Senate to pass the Advancing Hope Act of 2016, which would extend the Rare Pediatric Priority Review Voucher Program - which was scheduled to expire on September 30th - through the end of the year. The program is a critical incentive in promoting research into rare diseases affecting children, and has been a tremendous success since its enactment in 2012 - helping to spur the development and approval of six new therapies for seven rare diseases that previously lacked an FDA-approved therapy.

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  4. FDA Approves Amgen's AMJEVITA (Adalimumab-Atto) For Treatment Of Seven Inflammatory DiseasesRead the original story

    Friday Sep 23 | Digital Post Production

    /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab). AMJEVITA is the first ...

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  5. FDA approves lower-cost alternative to biotech drug HumiraRead the original story w/Photo

    Friday Sep 23 | The Daily News-Record

    Federal regulators have approved the first alternative version of the second-biggest selling drug in the world, AbbVie's Humira, a blockbuster injection used to treat rheumatoid arthritis and other inflammatory diseases. The Food and Drug Administration cleared the near-copy of the drug, dubbed Amjevita, developed by Amgen Inc. of Thousand Oaks, California.

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  6. Waymouth Farms, Inc. Issues an Allergy Alert on Undeclared Pecans,...Read the original story

    Friday Sep 23 | US Food and Drug Administration

    ... mers and sincerely regret any inconvenience. We are working and cooperating fully with the U.S. Food and Drug Administration on this voluntary recall.

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  7. BRIEF-FDA approves Amgen's AmjevitaRead the original story w/Photo

    Friday Sep 23 | Reuters

    WASHINGTON, Sept 23 The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira.

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  8. Keith Lamont Scott's wife releases video of shootingRead the original story w/Photo

    Friday Sep 23 | The Fresno Bee

    ... bee health and funding for a new Honey Bee and Pollinator Research Center at WSU. The U.S. Food and Drug Administration finalized a new version of the nutrition label for packaged foods that reflects new scientific information. It is also designed ...

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  9. PolitiFact and Africa Check look into a conservative website's accusations.Read the original story w/Photo

    Friday Sep 23 | POZ

    ... In fact, a host of regulatory agencies have found the drugs in question to be safe. The U.S. Food and Drug Administration said there was no evidence the drugs themselves were substandard. The World Health Organization, South Africa's Medicines ...

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  10. China's CRRC, Bombardier to join forces on international bidsRead the original story w/Photo

    Friday Sep 23 | Reuters

    ... as part of a strategy to modify the company's ownership structure. WASHINGTON, Sept 23 The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. WASHINGTON, Sept 23 Former ...

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  11. UPDATE 1-Brazil's Amaro family sells 6.47 pct of LATAM AirlinesRead the original story w/Photo

    Friday Sep 23 | Reuters

    ... Esposito; Editing by Sandra Maler; Writing by Anthony Esposito) WASHINGTON, Sept 23 The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. MONTREAL, Sept 23 Canada's ...

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  12. Blue Bell: New listeria concern was first found in ice cream made at Brenham plantRead the original story w/Photo

    Friday Sep 23 | Dallas Morning News

    Robert Horton, route supervisor for Blue Bell Ice Cream, fills a refrigerated ice cream display in Dallas. Blue Bell ice cream that's now the focus of a 10-state recall actually passed a test for the presence of listeria but was recalled because of problems that surfaced at the company's Texas plant.

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  13. 45 Congressmen Ask DEA Not to Ban Kratom Next WeekRead the original story

    Friday Sep 23 | US News & World Report

    ... "similar in terms of pharmacology" to a drug called Oliceridine that currently is undergoing Food and Drug Administration-approved phase three trials in humans. Columbia University researchers currently are scrambling to complete research for a ...

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  14. FDA approves expanded indications for Ilaris for three rare diseasesRead the original story

    Friday Sep 23 | PressReleasePoint

    The U.S. Food and Drug Administration today approved three new indications for Ilaris . The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients: All three syndromes are hereditary diseases that are characterized by periodic attacks of fever and inflammation, as well as severe muscle pain.

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  15. Office of Justice Programs Announces Grant Awards of More Than $8.8...Read the original story

    Friday Sep 23 | PressReleasePoint

    ... of National Drug Control Policy, the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the Substance Abuse and Mental Health Service Administration. Today's awards were announced as part of Prescription ...

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  16. BRIEF-U.S. FDA approves Amjevita, a biosimilar to HumiraRead the original story w/Photo

    Friday Sep 23 | Reuters

    WASHINGTON, Sept 23 The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. MONTREAL, Sept 23 Canada's Bombardier Inc and the China Railway Rolling Stock Corporation , longstanding partners in the Chinese domestic rail market, said on Friday they had expanded their relationship to join forces on international bids.

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  17. Maryland joins suit against drug maker as overdoses riseRead the original story w/Photo

    Friday Sep 23 | Norwalk Citizen News

    ... tablets were not on the market. Through a series of unfounded safety concerns to the Food and Drug Administration , the attorneys general alleged in their lawsuit, the pharmaceutical company interfered in the sale of generic versions of Suboxone ...

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  18. FDA approves Amgen's cheaper copy of arthritis drug HumiraRead the original story w/Photo

    Friday Sep 23 | Reuters

    The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. The drug, Amjevita, known also as adalimumab-atto, was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn's disease, psoriasis and other conditions.

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  19. Serious injuries rare at popular obstacle coursesRead the original story w/Photo

    Friday Sep 23 | Reuters

    ... avoid or walk around higher risk obstacles, particularly electric shocks. WASHINGTON The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. (Reuters Health) - Stroke ...

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  20. UPDATE 1-Yahoo faces growing scrutiny over when it learned of data breachRead the original story w/Photo

    Friday Sep 23 | Reuters

    ... by Dustin Volz; Editing by Jonathan Weber and Cynthia Osterman) WASHINGTON, Sept 23 The U.S. Food and Drug Administration on Friday approved Amgen Inc's biosimilar version of AbbVie's top-selling arthritis drug, Humira. MONTREAL, Sept 23 Canada's ...

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