TagFDA

FDA Approves Cabenuva, the First Complete Long-Acting Injectable HIV Treatment

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Poz.com, January 21, 2021 On January 21, the Food and Drug Administration (FDA) in the USA approved the first complete injectable HIV treatment regimen that does not require daily pills. Cabenuva, from ViiV Healthcare, is administered only once a month. It is approved for people with an undetectable viral load on their current therapy who wish to switch to a long-acting regimen. Cabenuva consists...

U.S. FDA Approves Evofem Biosciences’ Phexxi™, the First Non-Hormonal Prescription Gel for the Prevention of Pregnancy

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Evofem Biosciences via PRNewswire, May 22nd 2020  Evofem Biosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Phexxi is the first non-hormonal, on-demand...

The battle over Essure

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The Washington Post, Published on July 26, 2017 Nobody can say exactly how many women have had Essure implanted since the device went on the market in 2002. Bayer, which is headquartered in Germany, says that more than 750,000 devices have been sold worldwide and that sales “continue to grow.”  In recent years, the [US] Food and Drug Administration has received more than 16,000 adverse-event...

HIV prevention drug PrEP being tested on high-risk adolescents

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Sydney Morning Herald, July 21 2016
A preventative HIV drug being used by thousands of gay men in Australia is being tested on teenagers at high risk of the virus.
Studies have shown that PrEP (pre-exposure prophylaxis) offers near complete protection against HIV if taken properly every day. Researchers are now testing it on young people in South Africa and the US.
Read more here

New approach to women’s HIV prevention being studied in U.S. teens

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UAB News, June 17, 2015 Researchers at the University of Alabama at Birmingham continue efforts to find safe and effective HIV-prevention methods with a new study in female U.S. teens. The latest study to be led by UAB, MTN-023/IPM 030, is a Phase IIa study evaluating the safety and acceptability of a vaginal ring containing an antiretroviral (ARV) drug called dapivirine among teenage girls ages...

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