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 The U.S. Food and Drug Administration (FDA) recently released a draft guidance outlining how drug…
Read MoreDrug Evaluation and Research
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…
Read More
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…
Read More
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)…
Read More
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…
Read More
FDA Approves Medication for Obstructive Sleep Apnea
First OSA drug treatment for obese adults offers new hope alongside diet and exercise. The FDA recently approved Zepbound (tirzepatide) as the first drug treatment for moderate to…
Read More
FDA Moves to Eliminate Oral Phenylephrine from OTC Nasal Decongestants
Review finds oral phenylephrine ineffective, leading to a proposal for market removal. The U.S. Food and Drug Administration (FDA) recently proposed removing oral phenylephrine from over-the-counter (OTC) products…
Read More
FDA Approves New Hemophilia Treatment Hympavzi
Novel therapy targets blood-clotting proteins to prevent bleeding episodes. The U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab) as a novel treatment for hemophilia. The drug…
Read MoreFDA Approves New Schizophrenia Treatment with a Breakthrough Mechanism
Cobenfy offers an alternative that addresses symptoms of schizophrenia with a different approach. The U.S. Food and Drug Administration (FDA) recently approved Cobenfy (xanomeline and trospium chloride) for…
Read More