FDA related Press Releases

FDA Announces Steps to Improve Advisory Committee Processes The Food and Drug Administration is announcing several steps to strengthen its advisory committee processes in ways consistent with Read more...

FDA Sends Sanofi Warning Letter for Ketek Study ROCKVILLE, Md., Oct. 24, 2007--The FDA posted on its web site a letter to Sanofi-aventis regarding a study with the antibiotic Ketek. DEPARTMENT OF Read more...

OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed WASHINGTON, Sept. 28, 2007—Weaknesses in the Food and Drug Read more...

FDA Clears Genetic Lab Test for Warfarin Sensitivity The U.S. Food and Drug Administration today cleared for marketing a new genetic test that will help physicians assess whether a patient may be Read more...

Cephalon Warns Doctors Over Pain Drug Deaths Says FDA FRAZER, Pa., Sept. 13 -- Cephalon, Inc. today communicated with healthcare professionals to clarify the appropriate patient selection, dosing Read more...

FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol Committees also recommend further changes to US Label for Trasylol and additional safety studies Leverkusen, Read more...

Ariad Pharmaceuticals Says Reaches Agreement with FDA for Cancer Drug Trial CAMBRIDGE, Mass. -- ARIAD Pharmaceuticals today announced that it has reached agreement on a Special Protocol Assessment Read more...

GTC Obtains FDA Fast Track Designation for ATryn and Permission to Submit a Rolling BLA FRAMINGHAM, Mass. -- GTC Biotherapeutics announced today that the US Food and Drug Administration, or FDA, Read more...

FDA Announces Baraclude (entecavir) is Not Recommended for HIV/HBV Co-infected Patients Who Are Not Also Receiving HAART Due to the Potential for the Development of HIV Resistance ROCKVILLE, Md.,

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Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children - Zingo is First Commercial Product for Anesiva - SOUTH SAN

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