The Phase III METEOROID study met its primary endpoint, with ENSPRYNG cutting the risk of a first relapse by 68% compared to placebo in adults and adolescents
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
It provides an option to automatically perform nodule detection immediately after chest X-ray imaging
The first patient dosed with VX-880 demonstrated restoration of insulin production and achieved C-peptide of 560 pmol/L in response to Mixed Meal Tolerance Test (MMTT) at Day 90 visit
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