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Browsing Tag

U.S. Food and Drug Administration; United States Food and Drug Administration; FDA; Food and Drug Administration (FDA); Food and Drug Administration

12 posts
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FDA Panel Rejects Combo Drug for PTSD
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FDA Panel Rejects Combo Drug for PTSD

  • 23 July 2025
An FDA advisory panel has resoundingly rejected the supplemental new drug application for the atypical antipsychotic brexpiprazole (Rexulti,…
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First New PTSD Drug in Two Decades On the Horizon?
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First New PTSD Drug in Two Decades On the Horizon?

  • 18 July 2025
The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a…
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photo of Gamifant
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FDA Approves First Treatment for MAS in Still Disease

  • 1 July 2025
The FDA has approved the interferon gamma-blocking antibody emapalumab-lzsg (Gamifant) for the treatment of macrophage activation syndrome (MAS)…
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Injectable HIV Prevention Drug Gets FDA Nod
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Injectable HIV Prevention Drug Gets FDA Nod

  • 21 June 2025
Individuals at risk for sexually acquired HIV have a new injectable option for preexposure prophylaxis (PrEP) with the…
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FDA Approves Triple Rx for Hypertension
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FDA Approves Triple Rx for Hypertension

  • 12 June 2025
The FDA has approved Widaplik, a triple-drug combination, for the treatment of hypertension in adults. Widaplik combines three…
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Clinicians Push FDA on NarxCare
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Clinicians Push FDA on NarxCare

  • 23 May 2025
This article is the second in a series on prescription drug monitoring programs and analysis tools designed to…
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FDA Issues Warning on ‘Gas Station Heroin’ Tianeptine
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FDA Issues Warning on ‘Gas Station Heroin’ Tianeptine

  • 14 May 2025
The US Food and Drug Administration (FDA) has issued a health warning regarding products containing tianeptine, which is…
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FDA Okays Upadacitinib for Giant Cell Arteritis
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FDA Okays Upadacitinib for Giant Cell Arteritis

  • 30 April 2025
The US Food and Drug Administration (FDA) has approved a new indication for upadacitinib as a treatment for…
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FDA Issues Alert on Compounded Topical Finasteride Risks
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FDA Issues Alert on Compounded Topical Finasteride Risks

  • 24 April 2025
The US Food and Drug Administration (FDA) said Tuesday it has become aware of reports of adverse events…
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FDA Authorizes First Digital Therapeutic for Migraine
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FDA Authorizes First Digital Therapeutic for Migraine

  • 19 April 2025
The US Food and Drug Administration (FDA) has granted marketing authorization to CT-132 (Click Therapeutics), an adjunctive, first-in-class…
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