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FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 2 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...
FDA Announces Final Regulation Governing Laboratory Developed Tests | JD Supra
JD Supra· 23 hours agoThe U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will ...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI via Yahoo News· 8 hours agoIn a move that health experts say may reduce the number of fentanyl deaths, the FDA has approved over-the-counter sales of Narcan nasal spray. Now that it is more readily ...
FDA Approves New Treatment for Urinary Tract Infections, What to Know
Healthline· 6 days agoThe Food and Drug Administration (FDA) recently approved a new antibiotic to treat urinary tract...
FDA approves first targeted therapy for WHIM syndrome By Investing.com
Investing.com· 3 days agoX4 Pharmaceuticals (NASDAQ:XFOR) announced today the U.S. Food and Drug Administration (FDA) has...
FDA approves INGREZZA SPRINKLE for swallowing difficulties By Investing.com
Investing.com· 1 day agoNeurocrine (NASDAQ:NBIX) Biosciences, Inc. (NASDAQ:NBIX) today announced that the U.S. Food and Drug...
BrioHealth Solutions Secures Nod from FDA to Begin the INNOVATE Trial Featuring the BrioVAD™ System...
FOX 59 Indianapolis· 16 hours agoBrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, today announced it has received FDA Investigational ...
FDA Establishes CDER Center for Clinical Trial Innovation (C3TI) | JD Supra
JD Supra· 23 hours agoC3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory decision-making. As ...
Bird flu testing shows more dairy products are safe, US FDA says
Reuters via Yahoo Finance· 13 hours agoThe U.S. Food and Drug Administration said on Wednesday that preliminary results of additional testing of more dairy products has shown that pasteurization inactivates the bird flu virus. The ...
The FDA and Gene Therapy for Duchenne Muscular Dystrophy
Journal of the American Medical Association· 1 day agoThe US Food and Drug Administration (FDA) grants accelerated approval that includes the standard of a surrogate outcome that is “reasonably likely” to predict clinical benefit ...
