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JD Supra: Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests
JD Supra· 3 hours agoThe US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of ...
Explainer: what will the FDA’s food division restructure achieve?
Just Food via Yahoo Finance· 9 hours agoIn many ways, changing the culture of the agency is more critical than any of the top-line...
FDA approves Moderna’s mRNA RSV vaccine for older adults
CNN via Yahoo News· 6 days agoThe US Food and Drug Administration has approved another vaccine that can help protect older people...
US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug By Reuters
Investing.com· 7 hours agoThe drug is a potential rival to Eisai and Biogen (NASDAQ:BIIB)'s Leqembi, which won approval last July. Both treatments are antibodies designed to remove toxic beta amyloid plaques from the brains of people with early Alzheimer's disease.
FDA Staff Proposes Narrow Approval for Lilly’s Alzheimer’s Drug
Bloomberg· 8 hours agoUS drug regulatory staffers are considering a more targeted approval for Eli Lilly & Co.’s...
FDA approves Moderna’s mRNA RSV vaccine
The Hill via Yahoo News· 6 days agoThe Food and Drug Administration (FDA) has approved Moderna’s RSV mRNA vaccine for adults older than 60 years. The approval makes RSV the second disease...
US FDA approves Moderna's RSV vaccine with lower-than-expected efficacy in its label
Reuters· 6 days agoModerna's vaccine was approved for the prevention of RSV-associated lower respiratory tract disease...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 1 day agoRule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices. FDA published a four-year enforcement discretion phaseout plan as part ...
US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug
AOL· 7 hours agoBoth the drugs are antibodies designed to remove toxic beta amyloid plaques from the brains of people with early Alzheimer's disease. The panel will also vote on whether benefits of the treatment ...
FDA confirms robotic prostatectomy survival rates match traditional surgery By Investing.com
Investing.com· 1 day agoThe U.S. Food and Drug Administration (FDA) has approved a labeling revision for Intuitive's da...