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FDA Wants More Neutroval Information

[ Price : $8.95]

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

Crocker Ventures Acquires TMJ Implants

[ Price : $8.95]

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 ...

FDA OKs Orion sNADA for Cats

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Online Report Hits FDA Sunscreen Regulations Delay

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An online report faults FDA for taking more than 30 years to approve new sunscreen regulations.

Teva, Onco Genex Begin Phase 3 Trial in Metastatic Prostate Cancer

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Teva Pharmaceuticals and Onco Genex Pharmaceuticals initiate a Phase 3 trial SYNERGY to evaluate custirsen as as first line therap...

Novartis Agrees to Pay $423 Million in Off-label Case

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Novartis Pharmaceuticals agrees to pay $423 million in criminal and civil fines to resolve a U.S. Attorney's Office (Eastern Distr...