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FDA takes action to grant traditional approval of Leqembi™ (lecanemab, Eisai/Biogen) for the treatment of early Alzheimer’s disease with confirmation of elevated amyloid beta. This is the first traditional approval of an Alzheimer’s treatment that changes the underlying course of the disease.
Continue readingBreakthrough technology enables the world’s first beat-to-beat, wireless communication and synchronization between two leadless pacemakers, which are smaller than a AAA battery.
Continue readingThe study aims to compare outcomes for patients treated with the new low back total joint reconstruction to patients who received a traditional spinal fusion in a separate prospective study.
Continue readingThe FDA announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingApproval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.
Continue readingSuccessful completion of a pharma industry-sponsored study to measure the electrophysiologic effects of ketamine on healthy brain function.
Continue readingThe data from the PADN-CFDA pivotal study provides strong evidence for the treatment of pulmonary arterial hypertension.
Continue readingSuperior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids.
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