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Repros to Meet With FDA on Androxal Phase 3 Trial

[ Price : $8.95]

FDA and Repros will meet 11/8 to review the companys plans for two Androxal Phase 3 studies to treat hypogonadism.

EPA Upstages FDA on Dental Mercury

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Upstaging FDA regulatory efforts on mercury-containing dental amalgam, the Environmental Protection Agency announces it will indep...

FDA Warns Gilead on Plant Problems

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A Gilead SEC filing says the company received an FDA Warning Letter following an inspection at its San Dimas, CA, manufacturing fa...

Soccer Great Mia Hamm in GSK Vaccination Program

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Soccer star Mia Hamm is working with GlaxoSmithKline to promote adult vaccinations.

FDA Wants More Neutroval Information

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An FDA complete response letter on Tevas Neutroval BLA asks for more information but no more clinical trials.

Crocker Ventures Acquires TMJ Implants

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FDA-besieged TMJ Implants is sold at a bankruptcy auction for $455,00 to health science investment company Crocker Ventures, who s...

Committee Recommends Celsion Continue Phase 3 Liver Cancer Trial

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A data monitoring committee recommends that Celsion Corp. continue enrollment of its Phase 3 clinical study of Thermodox for prima...

FDA OKs Orion sNADA for Cats

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Federal Register Final rule: FDA approves an Orion Corp. supplemental NADA for use of dexmedetomidine hydrochloride as a preanesth...

FDA Clarifies P&U sNADAs for Heifer Feed

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Federal Register Final rule: FDA amends the animal drug regulations to accurately reflect a recent approval of two Pharmacia & Upj...

FDA Sends Info to OMB on ID Testing of Dietary Ingredients

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Federal Register Notice: FDAs proposed collection of information on a petition to request an exemption from 100% identity testing ...