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Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL® in ...
Published January 9, 2009, 5:39 am, Business Wire via Yahoo! Finance
WHITEHOUSE STATION, N.J.----Merck & Co., Inc. announced today that the U.S. Food and Drug Administration has issued a second complete response letter regarding the supplemental biologics license application for the use of GARDASIL® [Human Papillomavirus Quadrivalent Vaccine, Recombinant ] in women ages 27 though 45.
Advaxis' Phase II Clinical Trial "HOLD" Lifted
Published January 8, 2009, 7:10 am, Medical News Today
Advaxis Inc (OTCBB: ADXS), a biotechnology company, received permission from the U. S. Food and Drug Administration (FDA) to test its lead drug candidate, Lovaxin C, in patients with grade 2/3 cervical intraepithelial neoplasia (CIN). With this approval of the Investigational New Drug (IND) application for Lovaxin C, the FDA "HOLD" on Advaxis' clinical program has been lifted.
Advaxis Phase II Clinical Trial HOLD Lifted
Published January 6, 2009, 7:00 am, Business Wire via Yahoo! Finance
NORTH BRUNSWICK, N.J.----Advaxis Inc , a biotechnology company, received permission from the U. S. Food and Drug Administration to test its lead drug candidate, Lovaxin C, in patients with grade 2/3 cervical intraepithelial neoplasia .
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