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How we plan to cut FDA drug approval time by months
Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...
FDA approves new twice-yearly HIV shot. What to know
The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show ...
FDA approves long-lasting HIV-prevention drug
The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and ...
FDA approves powerful HIV drug that nearly eliminated spread in clinical trials
The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported ...
FDA approves the world's only twice-a-year shot to prevent HIV
The U.S. Food and Drug Administration has approved the world’s only twice-a-year shot to prevent HIV. (Scripps News) ...
FDA approves HIV prevention drug taken as twice-yearly injection
Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...
The FDA Approves Powerful HIV Prevention Drug
But the Trump administration’s cuts to HIV programs in the U.S. and abroad could undermine the drug’s rollout.
FDA approves first twice-yearly injection that prevents HIV infection
The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent ...
FDA says Americans' DNA sent to foreign labs in clinical trials
The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ ...
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FDA approves new twice-yearly HIV prevention shot. Here's how it works
In two recent studies, this new shot reportedly nearly eliminated new infections in people at substantial risk of HIV.
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FDA’s gene therapy turmoil, and an alternative model for funding research
We look at the continued turmoil within the FDA, including the forced dismissal of top gene therapy regulator Nicole Verdun, as well as the announcement of a controversial drug-review voucher program ...
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FDA OKs new HIV shot taken just twice a year
The FDA has approved Gilead’s long-anticipated HIV prevention shot, Yeztugo, offering a twice-a-year alternative to daily ...