FDA application accepted for HIV drug with new mechanism of action

MONTREAL, Canada – Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced Friday that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will…

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FDA launches public education campaign to prevent and reduce tobacco use among LGBT young adults

The U.S. Food and Drug Administration today announced the launch of a historic public education campaign aimed at preventing and reducing tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults ages 18-24. Of the more than 2 million LGBT young adults in the U.S., more than 800,000 smoke occasionally. The “This Free Life”…

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Transgender people and the FDA’s new blood donation guidelines

Dec. 21, the Food and Drug Administration (FDA) issued final blood donation guidelines. The policy updated blood donor deferral recommendations, which they stated would reflect “the most current scientific evidence and to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products.”…

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FDA releases revised recommendations for reducing the risk of HIV transmission by blood and blood products

WASHINGTON — The Food and Drug Administration (FDA) has released final guidance  on a long-awaited change to the current blood donation ban on gay and bisexual men.  The guidance released today outlines the implementation of a deferral-based policy utilizing a one year period of abstinence from same-sex sexual activity for men. Today’s final guidance also…

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Assemblymembers Bloom, Garcia and Low Join EQCA in urging the FDA to develop blood donation policies based on risk assessment

Assembly Joint Resolution (AJR) 16, authored by Assemblymembers Richard Bloom, Eduardo Garcia and Evan Low and sponsored by Equality California, has been introduced in the State Assembly in response to the Food and Drug Administration’s (FDA) new blood donor guidelines that continue to discriminate against gay and bisexual men. The new proposed FDA guidelines would…

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FDA recommends ending ban on blood donations from gay and bisexual men

The Food and Drug Administration (FDA) has recommended the end of a three-decade ban on blood donations from homosexual and bisexual men. However, some restrictions will remain, and the FDA’s recommended policy will bar donations from men who have had gay sex in the previous year. In a press statement the FDA said, Over the…

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