The FDA has granted marketing authorization to Click Therapeutics for its digital therapeutic, CT-132, designed for the preventive treatment of episodic migraines in adults aged 18 and older. This approval marks a significant milestone for the over 37 million U.S. adults affected by migraines. CT-132, which received FDA Breakthrough Device Designation in 2022, is intended for use alongside other acute and preventive treatments. The authorization is supported by the ReMMi-D trial, which successfully met its primary endpoint by reducing monthly migraine days in patients on standard migraine medications. Additionally, the ReMMiD-C study demonstrated that CT-132’s performance was comparable in patients using calcitonin gene-related peptide inhibitors. This digital solution, accessible via a smartphone app, enhances treatment accessibility and expands care options for migraine sufferers.
Association of Migraine Disorders®
@MigraineDisordr
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Apr 11 The FDA has approved a new drug for the acute treatment of migraine with or without aura in adults. Molly O’Brien has the details and when it becomes available in this #MigraineMinute News update.For more details: https://l8r.it/ECez
Market Rebellion
@MarketRebels
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Apr 10 DXCM jumps 10% as FDA clears Dexcom G7 15 Day CGM system for adults with diabetes. Launch set for H2 2025 in the US, says Dexcom
@petenajarian
@MXLESQ
FREE WEBINAR:TODAY AT 4PM ET https://loom.ly/TCGGhvM
Gene Investing w/Anthony
@GeneInvesting
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Apr 10 WOW“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans
Laura
@LauraDeming
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Feb 26 GO LOYAL!!!!!!!!!!the ramifications of these FDA acceptances for efficacy data supporting lifespan extension for the longevity field at large are huge.these have been some of the most important milestones ever in the field, and the way in which they are/will impact
Derya Unutmaz, MD
@DeryaTR_
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Apr 10 This is a truly groundbreaking decision by the FDA. It will greatly accelerate the development of monoclonal antibody therapies, which can be described as “smart missiles” for their precision-making them exceptionally effective and specific.
Danielle Besley
@DanielleBesley
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Apr 14 “On Thursday, the U.S. Food and Drug Administration announced that it is “taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.””
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