The US Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA).
The tablet formulation can either be swallowed whole or dispersed in a teaspoon of filtered (non-chlorinated) water.
A pioneering team at St Jude Children's Research Hospital in the US say they successfully treated a child diagnosed with SMA ...
The approval of the Evrysdi tablet was based on the results of a bioequivalence study, which demonstrated that the 5-mg tablet, either swallowed whole or dispersed in filtered water, provided ...
The FDA has approved Merilog (insulin-aspart-szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. The regulatory ...
Evrysdi is the only non-invasive disease-modifying ... same demonstrated efficacy and safety as the currently available oral solutionNew tablet formulation may provide greater freedom and ...
Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 (off OCS treatment and only treated with Dupixent for at least 20 ...
Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids (OCS) taper by week 16 (off OCS treatment and only treated with Dupixent for at least 20 ...
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