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Dendreon Receives FDA Acknowledgement of Complete Response 21 Nov 2009 04:30 GMT
... SEATTLE, Nov. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGEÂ® (sipuleucel-T) ...
UPDATE: FDA Reviewing Safety Of Weight-Loss Drug Meridia 21 Nov 2009 02:14 GMT
... UPDATE: FDA Reviewing Safety Of Weight-Loss Drug Meridia (Updates ... FDA and Abbott) WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety ...
UPDATE 2-US FDA reviewing Abbott diet drug risks 21 Nov 2009 00:30 GMT
... Early findings suggest higher heart risks - FDA * FDA making no conclusions, analysis ongoing ... a higher risk of cardiovascular problems, the Food and Drug Administration said on Friday. "The analysis of these ...
Lawyer Applauds FDA Crackdown On Use Of Pain Pumps After Shoulder Surgery 21 Nov 2009 09:13 GMT
... and the anesthetics that are used for In announcing the new warnings requirement, the FDA analyzed 35 reports of shoulder chondrolysis reported to the FDA from 2006 to 2008. Each of the patients developed ...
UPDATE 1-US FDA reviewing Abbott diet drug risks 21 Nov 2009 01:44 GMT
... Early findings suggest higher heart risks - FDA * FDA making no conclusions, analysis ongoing ... a higher risk of cardiovascular problems, the Food and Drug Administration said on Friday. "The analysis of these ...

FDA Reviewing Safety Of Weight-Loss Drug Meridia 21 Nov 2009 02:14 GMT
... FDA Reviewing Safety Of Weight-Loss Drug Meridia By ... DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- The Food and Drug Administration Friday said it was conducting a safety ...
FDA Panel Finds Tiotropium Safe for COPD Patients 21 Nov 2009 02:36 GMT
... An FDA committee has decided that data allay concerns about the risk of stroke and cardiovascular events previously associated with ...
FDA approves sNDA for pediatric autism drug ABILIFY 21 Nov 2009 05:37 GMT
... display an ability to regulate their behavior or to delay gratification in... The U.S. Food and Drug Administration (FDA) has approved a new indication for Symbyax (olanzapine an... Roughly 10 million years ago, ...
FDA approves Pfizer's Geodon Capsules for the adjunctive maintenance treatment of bipolar disorder 21 Nov 2009 06:57 GMT
... Pfizer today announced that the U.S. Food and Drug Administration (FDA) has approved Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as ...
FDA Advisory Committee Finds Data Support The Claim That SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations 21 Nov 2009 03:12 GMT
... The U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee voted 11 to 1 that clinical data included in a ...

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FDA Debars Two Clinical Investigators, One for Selling Counterfeit Drugs 21 Nov 2009 00:59 GMT
... FDA Debars Two Clinical Investigators, One for Selling Counterfeit Drugs The FDA is permanently barring two clinical investigators from ...
Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent 21 Nov 2009 04:30 GMT
... Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval to market its WallFlexÂ® Fully Covered Esophageal Stent for the ...
FDA Warning Letter for Deconsal: Cornerstone Therapeutics preparing a response 21 Nov 2009 05:37 GMT
... had received a Warning Letter from the Food and Drug Administration ("FDA") alleging that its Deconsal CT chewable ... is preparing an appropriate response to the FDA. Cornerstone has not sold any Deconsal CT ...
FDA Issues Health Notice on NPWT Complications 21 Nov 2009 06:52 GMT
... FDA Issues Health Notice on NPWT Complications It's business as usual for makers of negative pressure wound therapy (NPWT) systems ...
Par's Generic Ultram ER Approved by the FDA 21 Nov 2009 06:57 GMT
... Par’s Generic Ultram ER Approved by the FDA Par Pharmaceutical won FDA approval and 180 days of marketing exclusivity for a generic version of Ortho-McNeil's pain-management ...
FDA Issues Warning Letters to 22 Internet Drug Sellers 21 Nov 2009 06:57 GMT
... FDA Issues Warning Letters to 22 Internet Drug Sellers Internet sites that sell pharmaceuticals to U.S. consumers received a ...
FDA Delays NDA Review for Exalgo Extended-Release Tablets 21 Nov 2009 00:59 GMT
... FDA Delays NDA Review for Exalgo Extended-Release Tablets CDER pushed back the Prescription Drug User Fee Act action date for ...
UPDATE 1-FDA OKs Abilify for child autism irritability 21 Nov 2009 01:20 GMT
... ANGELES, Nov 20 (Reuters) - The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co's ( ) ... disorder, the companies said on Friday. The FDA decision allows Abilify to be used in ...
Covidien says FDA extends Exalgo review 21 Nov 2009 01:42 GMT
... care company Covidien PLC said Friday the Food and Drug Administration will take longer than expected to review ... by three months, to Feb. 22. The FDA was scheduled to make a decision by ...
Industry: FDA Needs to Redraft Two Proposed CAD Guidances 21 Nov 2009 06:52 GMT
... Industry: FDA Needs to Redraft Two Proposed CAD Guidances Two draft guidances on computer-assisted detection (CAD) devices are so burdensome that ...

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Medtronic Working With FDA to Resolve Warning Letter 21 Nov 2009 06:52 GMT
... Medtronic Working With FDA to Resolve Warning Letter Medtronic's cardiac rhythm management unit has received a warning letter stemming from a Form ...
FDA Approves Aripiprazole to Treat Irritability Associated With Autistic Disorder 21 Nov 2009 06:54 GMT
... FDA Approves Aripiprazole to Treat Irritability Associated With ... -- November 20, 2009 -- The US Food and Drug Administration has approved aripiprazole (Abilify) for the treatment ...
Advanced Cell Technology Files IND With FDA For First Human Clinical Trial Using Embryonic Stem Cells To Treat Eye Disease 21 Nov 2009 07:11 GMT
... (OTCBB:ACTC) announced that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic derived retinal cells to treat ...
Unilever and FDA recall certain Shedd's Country Crock chilled side-dish products 21 Nov 2009 08:48 GMT
... and the side of the tub. In addition to working in cooperation with the FDA, the company is also issuing an alert through the Food Allergy & Anaphylaxis Network. chilled side-dish products are affected ...
FDA OKs Abilify For Autism-linked Irritability 21 Nov 2009 00:54 GMT
... ...