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FDA Approvals - GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix


GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009 (Medical News Today)
GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine Cervarix until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval.

Pharmaceutical companies say new approach by FDA has led to decrease approvals of new medications (News-Medical-Net)
An "intensifying focus on safety and a diminished tolerance for side effects" by FDA have "dramatically lowered" the chances that experimental medications will reach the market and have led to a recent decrease in approvals of new treatments, according to pharmaceutical companies, the Wall Street Journal reports.

Indian Generic Drug Company Cipla Receives FDA Approval For U.S. Sale Of Antiretroviral Zidovudine (Medical News Today)
Indian generic pharmaceutical company Cipla recently received full FDA approval to sell and market in the U.S. an oral generic version of the antiretroviral drug zidovudine, the Drug Industry Daily reports. Cipla's application for zidovudine was considered under the expedited review provisions of the President's Emergency Plan for AIDS Relief (Drug Industry Daily, 6/30).
 

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