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Posts tagged with "FDA"

Jan 4
FDA Approves First Drug to Treat Diarrhea in People With HIV The U.S. Food and Drug Administration (FDA) has approved Fulyzaq (crofelemer), the first drug to relieve symptoms of diarrhea that is a side effect of HIV antiretrovirals (ARVs). Intended for use among people with HIV who are taking ARVs and whose diarrhea is not caused by a virus, bacteria or parasite, the drug treats watery diarrhea that is a consequence of electrolyte secretion and water in the gastrointestinal tract. Read more… http://www.poz.com/articles/fulyzaq_crofelemer_salix_761_23339.shtml

FDA Approves First Drug to Treat Diarrhea in People With HIV

The U.S. Food and Drug Administration (FDA) has approved Fulyzaq (crofelemer), the first drug to relieve symptoms of diarrhea that is a side effect of HIV antiretrovirals (ARVs). Intended for use among people with HIV who are taking ARVs and whose diarrhea is not caused by a virus, bacteria or parasite, the drug treats watery diarrhea that is a consequence of electrolyte secretion and water in the gastrointestinal tract.

Read more… http://www.poz.com/articles/fulyzaq_crofelemer_salix_761_23339.shtml

Posted 4 months ago

1 note

Fulyzaq, Salix, diarrhea, HIV, AIDS, FDA, drugs,

Feb 16

FDA Gives Priority Review of Truvada as PrEP

The U.S. Food and Drug Administration (FDA) has accepted Gilead Sciences’ application to give priority review of Truvada (emtricitabine and tenofovir) as pre-exposure prophylaxis (PrEP), according to a Gilead statement. This PrEP is when an HIV-negative person takes a daily dose of Truvada as a means to lower the chance of contracting the virus during sex. The FDA grants fast-track appraisal to drug applicants that demonstrate major advances in treatment or provide a treatment where no adequate or current therapy exists. Approval of the supplemental New Drug Application (sNDA) will be discussed at the FDA Antiviral Drugs Advisory Committee in May. The target review date is June 15. 

(Source: poz.com)

Posted 1 year ago

1 note

U.S. Food and Drug Administration, FDA, Gilead, PrEP, pre-exposure prophylaxis, Truvada, HIV, AIDS,

May 26
First Do No Harm Research geared toward curing HIV is experiencing a resurgence. With new enthusiasm and increased funding, researchers are beginning to plot new interventions to bombard the virus in unusual ways. The first round of studies is bound to carry serious health risks, however, and many will fail. The big unanswered questions are whether HIV-positive people will volunteer for these trials—and if so, whether the FDA and other regulators will let them. Click here for more.

First Do No Harm

Research geared toward curing HIV is experiencing a resurgence. With new enthusiasm and increased funding, researchers are beginning to plot new interventions to bombard the virus in unusual ways. The first round of studies is bound to carry serious health risks, however, and many will fail. The big unanswered questions are whether HIV-positive people will volunteer for these trials—and if so, whether the FDA and other regulators will let them. Click here for more.

Posted 1 year ago

3 notes

HIV, FDA, Clnical Trials, POZ,

May 4
FDA Warns Companies Selling Fake Remedies for HIV The U.S. Food and Drug Administration (FDA) is sending dozens of warning letters to companies selling bogus pills and supplements that claim to cure or prevent sexually transmitted infections such as HIV, herpes and genital warts.

FDA Warns Companies Selling Fake Remedies for HIV

The U.S. Food and Drug Administration (FDA) is sending dozens of warning letters to companies selling bogus pills and supplements that claim to cure or prevent sexually transmitted infections such as HIV, herpes and genital warts.

Posted 2 years ago

3 notes

FDA, Drugs, HIV, STI,