The trial is being conducted by Roche in collaboration with Gilead Sciences.
Recordati Rare Diseases, Inc. announced the availability of Isturisa® (osilodrostat) tablets for the treatment of adults with Cushing disease for whom pituitary surgery is not an option or has not been curative. Isturisa is a cortisol synthesis inhibitor that works by blocking the enzyme 11-beta-hydroxylase, which is responsible for the final step of cortisol biosynthesis…
The FDA previously granted Fast Track and Orphan Drug designations to mepolizumab for the treatment of HES.
Treatment with ofatumumab (Novartis) was associated with a greater proportion of patients with relapsing forms of multiple sclerosis (RMS) achieving no evidence of disease activity (NEDA-3), compared with those who received teriflunomide, according to post hoc analysis of the phase 3 ASCLEPIOS trials.
Positive topline data was announced from the phase 3 ADAPT trial of efgartigimod (ARG-113; argenx) in adult patients with generalized myasthenia gravis (gMG).
The FDA has accepted for Priority Review the New Drug Application for lumasiran for the treatment of primary hyperoxaluria type 1.
Dupilumab was associated with clinical and anatomic improvements in patients with eosinophilic esophagitis, according to results from a pivotal phase 3 study.
Testing revealed that the product may have up to 115% of the labeled amount of Liothyronine (T3) (acceptable range is 90.0-110.0%).
The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
The FDA has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
