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FDA delays decision on drug to prevent HIV

The Food and Drug Administration is delaying by three months a decision on whether to approve a drug for preventing infection with HIV, the virus that causes AIDS. An agency decision on the drug Truvada, made by Gilead Sciences, was expected by June 15. But the decision was pushed back to give the agency time to review a new Gilead plan to limit the risks to healthy people taking the drug, Cara Miller, a company spokeswoman, said Friday.
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Truvada for HIV Prevention: FDA Review Is Favorable

Health : Healthland (3 years ago)

A pill that has long been used to treat HIV has moved one step closer to becoming the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS. The Food and Drug Administration said Tuesda... Read Post

Doctors To FDA: "HIV Prevention Pill" Not Ready For Approval

Health : Medical News Today (4 years ago)

Last week, a group of 55 U.S. physicians sent a letter to the U.S. Food & Drug Administration (FDA), urging the agency not to approve the use of Gilead's HIV/AIDS treatment drug Truvada for use as an HIV prevention pill - also known... Read Post

FDA Delays Decision on First Drug to Prevent HIV

Health : Healthland (3 years ago)

(WASHINGTON) — Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug’s manufacturer says. Gilead Sciences disclosed Friday that the Food and Drug Administrati... Read Post

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