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FDA Food & Drug Administration

Type: Organization

Name: FDA Food & Drug Administration (Food and Drug Administration, FDA, Federal Drug Administration)

Nationality: United States

Fact Sheet: Fact Sheet for Food and Drug Administration

First reported 20 hours ago - Updated 1 hour ago - 6 reports

Bayer AG

Xofigo Approval Keeps the Ball Rolling For Bayer Oncology

US-based Bayer Healthcare Pharmaceuticals, as its executives were quick to point out, has now received three new approvals for cancer indications in the last eight months.Bayer and Algeta's Xofigo employs a radioactive isotope to target bone metastas ... [Published Pharmaceutical Executive - 7 hours ago]

Entities: Bayer AG, bone metastases, Oncology, Stivarga

First reported 20 hours ago - Updated 8 hours ago - 5 reports

Thoratec Corporation

Thoratec Announces FDA Approval Of HeartMate II(R) Pocket Controller

Thoratec Announces FDA Approval Of HeartMate II(R) Pocket ControllerPLEASANTON, Calif., May 17, 2013 -- (Healthcare Sales & Marketing Network) -- Thoratec Corporation (THOR), a world leader in device-based mechanical circulatory support therapies to save, ... [Published Healthcare Sales & Marketing Network - 19 hours ago]

Entities: Thoratec Corporation, Patient, FDA Food & Drug Administration, congestive heart failure

First reported 16 hours ago - Updated 8 hours ago - 6 reports

Feds Sues New York Fish Company for Unsanitary Conditions

The U.S. Department of Justice in behalf of the U.S. Food and Drug Administration has filed a lawsuit against a New York fish company for processing fish under unsanitary conditions. The accusation was made against New York Fish Inc., makers of smoked ... [Published StudentNews.ie - 8 hours ago]

Entities: FDA Food & Drug Administration, Lawsuit, Regulatory Affairs, Mackerel

First reported 20 hours ago - Updated 9 hours ago - 7 reports

Oramed Pharmaceuticals Inc. Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.

— /PRNewswire/ --Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug ... [Published BioSpace - 15 hours ago]

Entities: Oramed Pharmaceuticals Inc, Insulin, FDA Food & Drug Administration

First reported 10 hours ago - Updated 9 hours ago - 2 reports

FDA Food & Drug Administration

3 Most Important Upcoming FDA Decisions of 2013

Filed under: InvestingRegulatory decisions made by the Food and Drug Administration (FDA) often serve as important catalysts for pharmaceutical stocks. In the following video, health-care analyst Max Macaluso discusses three upcoming FDA decisions -- ... [Published Daily Finance - 9 hours ago]

Entities: FDA Food & Drug Administration, Motley Fool, Merck & Co Inc

First reported May 17 2013 - Updated 9 hours ago - 3 reports

FDA, USP Enlist Industry’s Help in Improving OTC Drug Quality

FDA and U.S. Pharmacopeial Convention (USP) officials say proactive industry participation — mainly by offering up drug samples and technical information — is vital to improving the quality of OTC finished drugs, the subject of recent high-profile ... [Published FDA News - 9 hours ago]

Entities: FDA Food & Drug Administration, Drugs, Technical Information

First reported May 17 2013 - Updated 14 hours ago - 6 reports

FDA advisory committee to meet in July on opioid painkiller

Committee to consider QRxPharma's MoxduoRelated ContentSYDNEY — A Food and Drug Administration panel will consider whether to recommend approval for an experimental painkiller in July, the drug's developer said Friday.Australia-based QRxPharma said the ... [Published Drug Store News - 14 hours ago]

Entities: opioid, anodyne, FDA Food & Drug Administration, MoxDuo, QRxPharma Limited

First reported May 16 2013 - Updated May 17 2013 - 8 reports

Bayer's Xofigo receives US FDA approval for prostate cancer treatment

Bayer HealthCare, a sub-group of Bayer AG, has received the US Food and Drug Administration (FDA) approval for Xofigo (radium 223 dichloride) in treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no ... [Published PharmaBiz - May 17 2013]

Entities: Radium, bone metastases, Prostate Cancer, Bayer AG, Patient

First reported May 16 2013 - Updated May 17 2013 - 4 reports

FDA’s tobacco head plans to move quickly on industry issues

BY JOHN REID BLACKWELLRichmond Times-Dispatch Richmond Times-DispatchWILLIAMSBURG — The new head of the Food and Drug Administration’s tobacco agency pledged “efficient, effective and fair” regulation of tobacco products Thursday.“You all make a lawful ... [Published Richmond Times Dispatch - May 17 2013]

Entities: Tobacco, FDA Food & Drug Administration, FDA Center for Tobacco Products

First reported May 16 2013 - Updated May 17 2013 - 3 reports

LETTER: Aspartame experienced; it wasn’t good

Is the Food and Drug Administration (FDA) the “industry’s puppet”? I had a life-threatening, allergic reaction to “New Coke,” containing artificial sweeteners, in the 1980’s that required a fast trip to a doctor. Now, I won’t be able to drink chocolate ... [Published Farmshine - May 17 2013]

Entities: FDA Food & Drug Administration, Aspartame, Calorie, Chemical, Deadline

First reported May 16 2013 - Updated May 16 2013 - 4 reports

FDA issues warning to women using Ambien

Drug could affect driving the following day, agency saysORLANDO, Fla. -The Food and Drug Administration says women should not drive for an entire day after taking the drug Ambien.The FDA says research shows that the drug remains in the bloodstream at ... [Published Click Orlando - May 16 2013]

Entities: Ambien, FDA Food & Drug Administration, Drugs

First reported May 16 2013 - Updated May 16 2013 - 13 reports

Bayer Prostate Cancer Drug Gains FDA Approval

Bayer HealthCare said yesterday it is weeks away from joining Algeta in bringing to the U.S. market their advanced prostate cancer drug Xofigo® (radium Ra 223 dichloride) following approval yesterday by FDA.The second new prostate cancer treatment approved ... [Published Genetic Engineering News - May 16 2013]

Entities: Prostate Cancer, FDA Food & Drug Administration, Bayer AG, bone metastases

Quotes

"Whenever they’re buying something like that we want to be able to counsel the patient and make sure they understand the side effects and how to take it" he said

In Utah, nation confusion reigns over teen access to “morning after pill” [Published Salt Lake Tribune - 1 hour ago]

"I was able to tell them, basically the next morning when the sun came up, that the stuff was on the plane" Richart said

Doctor uses synthetic blood from Boston to save Jehovahâs Witness [Published Pueblo Chieftain Online - 2 hours ago]

Deuteronomy 12:23-25 says: "Simply be firmly resolved not to eat the blood, because the blood is the soul and you must not eat the soul with the flesh.You must not eat it. You should pour it out upon the ground as water.You must not eat it, in order that it may go well with you and your sons after you, because you will do what is right in Jehovahâs eyes." ------ Blood is not to be stored...how then can Hemopure be manufactured out of anything but stored blood?

Jehovahâs Witness experiences an influx of hope [Published Gainesville Times - 2 hours ago]

"Propofol is an effective anesthetic drug for colonoscopies and endoscopies because it is short acting and patients typically wake up quickly and feeling alert" says Janice Izlar, CRNA, DNAP, president of the 45,000-member AANA

Nurse Anesthetists Blast FDA Decision on Propofol Administration by Machine [Published Advance for Nurses - 4 hours ago]

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Adding Cetuximab Promising in Making Colorectal... [Published Oncology Times - 3 hours ago]
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Nurse Anesthetists Blast FDA Decision on Propof... [Published Advance for Nurses - 4 hours ago]
N.C. to get $8.74 million as part of settlement... [Published Winston-Salem Journal - 4 hours ago]

Blogs

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Change.org CEO shows how online petitions chang... [Published Venturebeat - 13 hours ago] When people run into major problems with the health industry — trying to get money from insurance companies or to get access to an experimental drug, for example — they’re no longer just turning to lawyers. Increasingly, they’re turning to online pet ...
Deals Of The Week Is Keeping Score – Valeant Wa... [Published The IN VIVO Blog - 13 hours ago] Whether the pastime is baseball, Broadway or the daytime soaps, the old adage is that you can’t keep track of the players without a scorecard. The M&A front involving specialty pharma and generic drug makers has become similarly frenzied, as Canada’s ...
Change.org CEO shows how online petitions chang... [Published Venturebeat - 13 hours ago] When people run into major problems with the health industry — trying to get money from insurance companies or to get access to an experimental drug, for example — they’re no longer just turning to lawyers. Increasingly, they’re turning to online ...
Weekly Roundup 5-17-13 [Published Eye on FDA - 14 hours ago] It has been a busy May. From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and posting final grades to end up ...
Big Pharma Firms Seeking .pharmacy Domain To Cr... [Published Techdirt - 15 hours ago] For years, we've noted that the big drug companies like to conflate legitimate foreign pharmacies (often based in Canada) that sell back into the US (the so-called "reimportation" or "parallel import" market) at cheaper prices with out and out bogus or ...

Audio/Video

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Sequestration will compromise ability for FDA t... [Published Reuters Video: Top News - May 06 2013]
Sequestration will compromise ability for FDA t... [Published Reuters Video: Business - May 06 2013]
"Plan B" morning-after pill access expanded to ... [Published CBS News Online - YouTube - May 01 2013]
Rogers Opening Statement at Food and Drug Admin... [Published Rep. Hal Rogers - YouTube Channel - Apr 26 2013]
Biotech's Next Big Thing: Aveo [Published TheStreet.com - YouTube - Apr 25 2013]

Press Releases

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Xylitol Canada Inc. Financial Results for Three... [Published PR inside - 11 hours ago]
Wright Medical Hip Lawsuit Update: New Video In... [Published Business Wire - 14 hours ago]
FDA Sets 17 July 2013 For MOXDUO® Advisory Comm... [Published PR Newswire - 19 hours ago]
Forest to Present Aclidinium Bromide and Roflum... [Published Business Wire - 20 hours ago]
Tech Council of Maryland Names GlycoMimetics CE... [Published Business Wire - 20 hours ago]