FDA

I’m still not sold on Sanjay Gupta for surgeon general. In fact, the more I think about it, the more I dislike the very idea of putting Gupta in charge of public health. As I wrote on Tuesday, when the story broke, Dr. Gupta “seems to be very much a part of, as well as a defender of, the status...  

Six months after the FDA rejected Merck and Co.'s request to approve the distribution of Gardasil - the HPV vaccine - to women aged 27 to 45, they've sent a response letter to Merck requesting that they resubmit their request after a full 48-month study. Merck's original application included...  

Anesiva Inc. said Friday the U.S. Food and Drug Administration approved its supplemental New Drug Application to expand the indication for its Zingo system to treat pain associated with blood draws to include adults. (ANSV)  

Big name pharmaceutical companies are still scrambling to take advantage of market bargains during the economic crisis. With many of them seemingly undaunted by the global credit crunch, we may see some big M&A announcements in the near future. Wyeth is reportedly making a play to acquire Dutch...  

Visit StreetInsider.com at http://www.streetinsider.com/Corporate+News/FDA+Issues+2nd+Complete+Response+Letter+for+Merck%27s+%28MRK%29+GARDASIL%3B+Reaffirms+FY09+Sales%2C+EPS+Guidance/4290101.html for the full story.  

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...  

Merck is seeking FDA approval for the use of its human papillomavirus vaccine, Gardasil, for boys and young men ages nine to 26, the Wall Street Journal reports. Merck is seeking the approval for the prevention of male genital warts and other lesions, for which Gardasil was shown effective in...  

WHITEHOUSE STATION, N.J. (AP) — Merck & Co. said Friday the Food and Drug Administration has again asked for more data before making a decision on expanding approval of the Gardasil human papillomavirus vaccine to include use by older women. The ...  

Dividend.comMerck Hits Another Delay For Wider Gardasil Use CNNMoney.com - 6 hours ago By Peter Loftus Merck & Co. (MRK) has hit another setback in its effort to widen the use of the Gardasil cervical-cancer vaccine to women up to age 45. Merck gets 2nd FDA delay on Gardasil expansion Forbes...  

By Steve Goldstein , , ) said the Food and Drug Administration wants more data before approving cervical cancer vaccine Gardasil in women ages 27 through 45 ...  

HHS Secretary Mike Leavitt, Assistant Secretary for Health Admiral Joxel Garca and HHS Food and Drug Administration (FDA) Commissioner Andrew von Eschenbach, M.D., are in Costa Rica today to mark the... [WebWire - Thursday, January 08, 2009]  

By Susan Heavey WASHINGTON, Jan 8 (Reuters) - A U.S. regulatory review of the controversial cholesterol drug Vytorin, made by Merck & Co Inc and ...  

Merck & Co. has submitted an application to the Untied States Food and Drug Administration (FDA) to consider Gardasil®, the vaccine against the human ...  

American Medical Systems said the Food and Drug Administration approved a separate prolapse treatment, AMS' Elevate Posterior Prolapse Repair System, ...  

Emergent BioSolutions Inc., maker of the only anthrax vaccine approved by the Food and Drug Administration, has given up trying to acquire the maker of a flu vaccine candidate. (EBS)