Drug Approval | March 12, 2026
FDA nod to first treatment for rare genetic brain disorder
The approval comes after a systematic review of published literature
The approval comes after a systematic review of published literature
Phase I EPRAD study of DT-9081 demonstrated a favorable safety profile
Diasens and GlucoLive are designed for diabetic, Chronic Kidney Disease (CKD), and post-transplant patients who require continuous glycaemic surveillance and integrated remote care
The Hydrus Microstent stands out as the first and only MIGS device backed by five-year clinical outcomes
Giredestrant shows promise despite missing primary goal
The agreement brings to market a method pioneered at CU Boulder that enables the reliable synthesis of long RNA strands
The study hit its primary goal, showing a statistically significant rise in participants achieving EASI-75
The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
Indomo’s ClearPen system combines a proprietary self-injection device and microneedle with a modernized triamcinolone acetonide formulation
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