An official says this is the first drug that addresses the underlying biology of the disease. The Food and Drug Administration (FDA) has approved Orzeyful (oveporexton), a drug used to…
Read MoreDrug Evaluation and Research
FDA Approves mRNA-Based Flu Vaccine
The Moderna vaccine has been authorized for adults aged 50-64. The Food and Drug Administration approved the Moderna mRNA-based flu vaccine this week, according to the pharmaceutical company.…
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VA and HHS Announce Psychedelic Drug Trials for Veteran Mental Health
The two organizations will partner together to increase the focus on clinical trials for psychedelic medications to treat serious mental illness. The U.S. Department of Health and Human…
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NIH Funds Clinical Trial to Treat Opioid Withdrawal in Newborns
Infants with NOWS have been treated with custom treatment plans, leading to a quicker recovery. The National Institutes of Health (NIH) reported an advanced treatment for infants experiencing…
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HHS Releases Guidance for Human-Based Research to Reduce Animal Testing
FDA and NIH announce actions to advance alternative research methods and validation frameworks. The U.S. Food and Drug Administration (FDA) recently released a draft guidance outlining how drug…
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NIH Survey Finds Teen Substance Use Remains Near Historic Lows
The study shows stable trends with isolated increases in certain substances. An annual survey, supported by the National Institutes of Health (NIH) and conducted by the University of…
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FDA Drafts New Guidance for the Development of Affordable Biosimilar Drugs
The new guidance seeks to lower development costs and improve patient access to safe, effective alternatives to high-cost biologic medicines. The U.S. Food and Drug Administration (FDA) recently…
Read MoreNIH Plans to Cap Payments for Publicly Published NIH Research
Follows up on 2022 White House directive, new policy set for 2026 implementation The National Institutes of Health (NIH) recently announced that, starting in 2026, it will cap…
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FDA Approves Qfitlia for Hemophilia Treatment
New medication offers less frequent doses to reduce bleeding episodes in patients with Hemophilia A and B. The U.S. Food and Drug Administration has recently approved Qfitlia (fitusiran)…
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FDA Approves First Treatment for Rare Disease
Ctexli offers hope for patients with a previously untreated metabolic disorder, Cerebrotendinous Xanthomatosis. The U.S. Food and Drug Administration (FDA) has approved Ctexli (chenodiol) as the first treatment…
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