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FDA News
2012-02-06
13WMAZFDA staff unsure about new use for Amgen's XgevaReutersThe FDA reviewers' concerns, raised in documents released on Monday, appeared to dim any serious hopes that an advisory panel of outside experts would recommend approval of an expanded use of Xgeva, viewed by analysts as a drug whose sales could reach ...FDA Questions Benefit of Amgen Bone Drug in Certain CasesWall Street Journal (blog)FDA questions benefit of Amgen's bone drug for new use in prostate cancer patientsWashington PostFDA Staff Questions Merit of Expanding Use of Amgen's XgevaBusinessWeekall 201 news articles »
2012-02-06
FDA News & Notes - Week of February 6, 2012MarketWatch (press release)FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Wednesday, 2/8 - The Oncologic Drugs Advisory Committee Meeting discusses a supplemental biologics application for Xgeva (denosumab) to treat men with ...and more »
2012-02-06
Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel ...Sacramento Bee6, 2012 -- /PRNewswire/ -- Neurelis, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence clinical trials advancing the development of NRL-1 for the ...and more »
2012-02-06
Plain DealerNortheast Ohio pet owners want fast FDA action on pet treats from ChinaPlain Dealer"I urge you to promptly pursue efforts to find the contaminant in these pet foods, alert customers of the dangers of these products, and make sure the products found harmful are pulled from the retail market," Brown said in a letter to FDA Commissioner ...Brown, Kucinich Seek FDA Action to Protect Dogs From 'Tainted' TreatsCleveland News - Fox 8Congressional leaders, pet owners want FDA action over reports of treats ...NewsNet5.comTainted pet treats are still available in storesWTAM.comall 4 news articles »
2012-02-06
Southwest Farm PressFDA says low fungicide levels in imported juice are acceptableSouthwest Farm PressThe FDA has indicated they are ready to accept EPA's acceptable levels of the fungicide—80 parts per billion—which do not pose a threat to public safety. Orange juice suppliers in the United States are breathing easier this week after the Federal ...Brazil's OJ industry drops US banned fungicideReutersINTERVIEW-UPDATE 2-Brazil limits US-bound OJ to non-concentratedReuters AfricaOrange Juice Imports DetainedChemical & Engineering NewsSun-Sentinel -FreshPlaza -BusinessWeekall 13 news articles »
2012-02-06
FDA taking away your vitamins?WND.comThis past summer, the FDA issued a draft of guidelines for complying with the New Dietary Ingredient (NDI) notification protocols. Translation: Any company or individual wishing to sell or develop a supplement containing new ingredients would have to ...Dietary Supplements Extensively Regulated, Say Authors of New ArticlePR Newswire (press release)ABC Article Outlines Supplement Regulation MythsNatural Products INSIDERAre Supplements Safe?IvanhoeNatural Standard Blog (blog)all 25 news articles »
2012-02-06
QUBYX Receives FDA 510(k) Clearance for the DELL UltraSharp U3011 With ...MarketWatch (press release)"We are very pleased to have now not only European CE Mark for PerfectLum software, but also the FDA clearance for the DELL 4 MP display and PerfectLum bundle," says Marc Leppla, Director of QUBYX. "The FDA clearance allows the bundle to officially ...and more »
2012-02-06
Orexigen, FDA agree on trial design for obesity drugReutersThe FDA declined to approve Orexigen's pill in January 2011, citing Contrave's cardiovascular effects when used long-term in a population of overweight and obese subjects. Contrave is one of three obesity drugs that the FDA has shot down over safety ...Orexigen, FDA Set Outcomes Trial Protocol For Diet Drug ContraveWall Street JournalOrexigen® Announces Agreement From the FDA on a Special Protocol Assessment ...MarketWatch (press release)Orexigen says it reached Agreement With FDA On SPA For Contrave Outcomes TrialRTT Newsall 26 news articles »
2012-02-06
FDA vs. Drug Ads: Cut the Kids and Dogs, Spell Out Side EffectsXconomyWell, the FDA isn't pleased with the pharmaceutical industry's advertising practices. So it's proposing a new set of rules that would not only limit the ability of drug advertisers to use so many cheerful images, but may indeed force them to place more ...FDA reopens comment period for proposed rule on prescription drug ads to ...Lexology (registration)all 2 news articles »
2012-02-06
FDA clears Ziopharm Oral Palifosfamide INDPharmaceutical Business ReviewThe US Food and Drug Administration (FDA) has accepted Ziopharm Oncology's investigational new drug (IND) application for the oral dosing of palifosfamide. Palifosfamide (Zymafos or ZIO-201) is a novel DNA cross-linker that in preclinical study has ...ZIOPHARM Announces FDA Acceptance of IND for Oral PalifosfamideMarketWatch (press release)Ziopharm Oncology Says FDA Accepts IND For Oral Palifosfamide - Quick FactsRTT NewsZiopharma hopes to expand biotechnology jobs with new FDA approvalMedReps (subscription)StreetInsider.com (subscription)all 9 news articles »
2012-02-06
Amgen has asked the FDA to approve the injectable drug Xgeva as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. Scientists for the Food and Drug Administration say that an Amgen Inc. drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried significant side ...
2012-02-06
WASHINGTON (Reuters) - Reviewers from Food and Drug Administration said they were not sure whether Amgen Inc's Xgeva bone drug should be also approved as a treatment to delay the spread of cancer to the bone. The FDA reviewers' concerns, raised in documents released on Monday, appeared to dim any serious hopes that an advisory panel of outside experts would recommend approval of an expanded use ...
2012-02-06
Scientists for the Food and Drug Administration say that an Amgen drug slowed the spread of cancer to the bone in men with hard-to-treat prostate cancer, though the drug did not extend life and carried ...
2012-02-06
SAN DIEGO, Feb. 6, 2012 /PRNewswire/ -- Neurelis, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared an Investigational New Drug application (IND) to commence clinical ...
2012-01-30
The Food and Drug Administration electronically spied on whistleblowers who alerted the Obama administration and Congress of alleged misconduct uin the agency, particularly relating to what they claim was the push to approve unsafe and ineffective medical devices, according to a lawsuit filed in federal court.
2012-02-06
Updated with analyst comments. THOUSAND OAKS, Calif. (TheStreet) -- Amgen's effort to expand the use of new drug Xgeva to prevent or delay the spread of prostate cancer to the bones of patients is being met with skepticism by U.S. regulators who question whether such a claim has merit since the drug doesn't help patients live longer and may cause more side effects. The U.S. Food and Drug ...
2012-02-06
WILMINGTON, DE-- - QUBYX Software Technologies Inc., an expert in color calibration and medical imaging fields, has announced that their bundle of the premium DELL UltraSharp U3011 display and PerfectLum ...
2012-02-06
SAN DIEGO, Feb. 6, 2012 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX - News) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol ...
2012-02-03
A group of former FDA scientists who spoke out against the agency's allegedly flawed device-approval process are suing the feds for intercepting Gmail and Yahoo Mail messages by installing spy programs on their work computers. Although the computers were owned by the government, the plaintiffs say they were explicitly granted the right to use them for personal purposes. Back in January 2009 ...
2012-02-06
SILVER SPRING, Md., Feb. 6, 2012 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of February 6, 2012.
2012-02-06
アメリカ医学界認可済みのサプリメント販売サイトL.A.XTACYへようこそ。米政府機関FDAの非常に厳しいガイドラインを満たした、ハーブやジンセンなど完全自然成分を使うことにより、副作用の一切無い、安全なサプリメントを提供しております。。http://j. #マカ
2012-02-06
@DestinyBaxter hold on.... HEY OBAMA, CEASE FDA TIES TO MONSANTO!!! NOW, DUDE. Ok, how's that?
2012-02-06
Tell the FDA to label genegically engineered food: Take action now! http://t.co/MTJwp35A via @Care2~ lets do something B4 they kill our kids
2012-02-06
Tell Obama to Cease FDA Ties to Monsanto http://t.co/siknVNoJ #signon
2012-02-06
Thanks! RT @RebarInter: @drjudystone's latest post at the SciAm blog. Plan B: The Tradition of Politics at the FDA – http://t.co/o7Mk1xEO
2012-02-06
The FDA is Killing You.: http://t.co/F4j4dpKw via @youtube
2012-02-06
RT @LeftSlashRight: Hey #Obama - I like you and all, but appointing a former MONSANTO lackey to the FDA is BAD FREAKING FORM. Gross. #p2 #tcot #tlot #left #ows
2012-02-06
Tell Obama to Cease FDA Ties to Monsanto http://t.co/eUTcRmrW #signon
2012-02-06
New Contrave Trials Approved by FDA #diet http://t.co/Y9I1h3yk
2012-02-06
RT @GreenCartoons: Tell Obama to Cease FDA Ties to Monsanto (quick petition) http://t.co/YMgofKWO #StopMonsanto
2012-02-06
FDA approval likely for once-daily COPD drug. (Dyspnea Claim Rejected).(chronic obstructive pulmonary disease): ... http://t.co/1OJw5wFj
2012-02-06
Tell Obama to Cease FDA Ties to Monsanto http://t.co/CUvO8MH3 #signon
2012-02-06
FDA Acknowledges Neuropsychiatric Side Effects of Singulair tco/1664CgUf Buy Singulair -> http://t.co/EfJvOTra
2012-02-06
Fab #gmo has hit the radar & folks know, to say no, to this feeding experiment! http://t.co/INTMvU8Y mt @dollarisavote http://t.co/MiKpxiQp
2012-02-06
Buy Tramadol Best pharmacy online Only FDA approved medications Your Reliable Online Pharmacy ijwnZV tco/BLD6OpEF... http://t.co/ZvcvkYOU
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