Food and Drug Administration

Food and Drug Administration Newswire (Page 7)

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  1. FDA delays Pozen experimental drugs' OK for 2nd timeRead the original story

    Wednesday Dec 17 | HeraldSun.com

    Pharmaceutical company Pozen said Wednesday that two versions of an experimental drug were denied approval for the second time by the Food and Drug Administration. John Plachetka, CEO of the Chapel Hill-based company, said in a conference call that the FDA cited the same reason as the first time, which was a deficiency in a third-party manufacturing facility that makes an active ingredient in the drug.

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  2. MomentumOF Jelly Beans and JournalistsRead the original story

    Jul 1, 2011 | American Reporter

    ... manufacturers must include all nine warnings in rotation on their packs. In addition, the Food and Drug Administration (FDA) also requires that one-fifth of every print ad must include the warnings. The FDA directive is based upon Congressional ...

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  3. Sterling International Consulting FZE, AL Mawarid Foodstuff Trading ink pactRead the original story w/Photo

    Friday | AME Info

    ... is a system of safety in food production and pharmaceuticals. The process is utilized by the Food and Drug Administration and the Department of Agriculture to ensure safe procedures and products. Expressing its happiness over its choice of Sterling ...

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  4. FDA Approves AstraZeneca Ovarian Cancer DrugRead the original story

    Friday | WRKO-AM Brighton

    The U.S. Food and Drug Administration approved the first drug to treat cases of ovarian cancer linked to specific genetic mutations.

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  5. Antidepressant Drug Stops Herpes Symptoms; CBCD Reviews the Medical EvidenceRead the original story w/Photo

    Friday | PRWeb

    "Tranylcypromine, marketed since the 1960s as Parnate, inhibited initial herpes infection in animal tests," according to a report published on ScienceNews.org on December 3, 2014. The CBCD reviews the evidence and recommends two natural HSV remedies.

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  6. FDA approves AbbVie combo hepatitis C treatmentRead the original story

    Friday | KDWN

    Patients with chronic hepatitis C have a new option for treating the liver-damaging virus, with the approval of a combination treatment developed by AbbVie. The Food and Drug Administration on Friday approved the sale of a packaged treatment called Viekira Pak made by AbbVie Inc. of North Chicago, Illinois.

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  7. FDA OKs Cubist antibiotic for serious infectionsRead the original story w/Photo

    Friday | Monterey County Herald

    The Food and Drug Administration has approved a new combination medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved this year. The approval of Zerbaxa is the second antibiotic approval this year for Cubist Pharmaceuticals, which agreed earlier this month to be acquired for $8.4 billion by the world's fourth-biggest drug maker, Merck & Co.

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  8. CDC urges avoiding caramel apples after deadly Listeria outbreakRead the original story w/Photo

    Friday | The Wichita Eagle

    ... are linked to the illnesses in order to find the source of the contamination. Working with the Food and Drug Administration, the CDC used DNA "fingerprinting" on bacteria from infected people to identify two outbreak clusters. "CDC is investigating ...

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  9. Kkot Saem Sprouts, Inc. Recalls Soybean Sprouts and Mungbean Sprouts Because of Possible Health RiskRead the original story

    Friday | US Food and Drug Administration

    ... on front of bag. This recall was the result of the sample collected and analyzed by the Food and Drug Administration and it is revealed that the finished mungbean sprouts contained Listeria monocytogenes . There have been no illnesses or deaths ...

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  10. US body accredits NAFDAC labRead the original story

    Friday | In-depth Africa

    The National Board of American Society for Quality has accredited the Regional Drug Laboratory of the National Agency for Food and Drug Administration and Control in Lagos. NAFDAC DirectorGeneral, Dr Paul Orhii, who made this known yesterday at a budget retreat for regulatory officers, said the agency's Yaba laboratory had now joined four accredited laboratories in the last one year.

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  11. Press release distribution, EDGAR filing, XBRL, regulatory filingsRead the original story

    Friday | Business Wire

    ... credit ratings (ICR) of "a" of Fireman's Fund Insurance Company (FFI... Enanta Announces U.S. Food and Drug Administration Approves AbbVie's VIEKIRA PAK (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic ...

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  12. FDA approves new drug for the treatment of ovarian cancerRead the original story w/Photo

    Friday | Examiner.com

    Angelina Jolie has candidly revealed her double mastectomy procedure to prevent breast cancer, but she still faces a risk of ovarian cancer. On December 19, 2014, the U.S. Food and Drug Administration approved Lynparza for the treatment of women with advanced ovarian cancer associated with defective BRCA genes.

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  13. FDA approves intravenous administration of ErwinazeRead the original story w/Photo

    Friday | Medical News

    Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze . Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity to E. coli -derived asparaginase.

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  14. UPDATE 2-U.S. FDA approves AbbVie hepatitis C drug, costs $83,319 for 12 weeksRead the original story

    Friday | Reuters

    ... anti-viral drugs to be taken as three pills in the morning and one in the evening. The U.S. Food and Drug Administration approved the regimen for patients with genotype 1 form of the virus, the most common type of hepatitis C and the most difficult ...

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  15. Enanta Announces U.S. Food and Drug Administration Approves AbbVie's...Read the original story

    Friday | Information Technology

    Enanta Announces U.S. Food and Drug Administration Approves AbbVie's VIEKIRA PAK for the Treatment of Chronic Genotype 1 Hepatitis C Virus Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field, today announced the U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK with or without ribavirin for the treatment of genotype 1 patients with chronic hepatitis C virus infection, including those with compensated cirrhosis. Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of three direct-acting antivirals in the VIEKIRA PAK regimen.

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  16. FDA approves new antibacterial drug ZerbaxaRead the original story

    Friday | PressReleasePoint

    The U.S. Food and Drug Administration today approved Zerbaxa , a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections . Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor.

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  17. Superbug-fighting Cubist antibiotic wins FDA nodRead the original story w/Photo

    Friday | Boston.com

    ... E. coli, and klebsiella pneumoniae. Zerbaxa is the first Gram-negative drug approved by the Food and Drug Administration under the new federal Generating Antibiotic Incentives Now law, known as the GAIN Act. That law gives drug makers priority ...

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  18. FDA Approves Cubist's Experimental Antibiotic ZerbaxaRead the original story

    Friday | WRKO-AM Brighton

    Cubist Pharmaceuticals' experimental antibiotic Zerbaxa has been approved by the U.S. Food and Drug Administration for treatment of certain urinary tract infections and intra-abdominal infections.

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  19. Select to View Firm Press ReleaseRead the original story

    Friday | US Food and Drug Administration

    FOR IMMEDIATE RELEASE December 19, 2014 New York, NY Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the . The firm was informed by the US Food and Drug Administration that a sample of SLIM-K collected and tested by the FDA was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.

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  20. Caramel apples could be carrying deadly listeria bacteriaRead the original story w/Photo

    Friday | KHQ-TV Spokane

    The CDC is warning Washington about a deadly listeriosis outbreak. They believe that prepackaged caramel apples could be carrying the bacteria listeria.

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