The approval was based on data from the phase 3 heiGHt trial, which compared Skytrofa to somatropin in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
The approval was based on data from the phase 3 heiGHt trial that assessed Skytrofa in 161 treatment-naïve, prepubertal patients with growth hormone deficiency.
The NDA submission includes data from the phase 3 SONICS and LOGICS studies that evaluated levoketoconazole in adults with endogenous Cushing syndrome.
The C0311002 study compared the patient perception of treatment burden with use of somatrogon to somatropin in 87 children aged 3 to 17 years with GHD.
Sogroya is administered by subcutaneous injection one time each week.
Mycapssa is an oral somatostatin analogue.
One nonfatal adverse event has been reported during the timeframe the affected product was distributed.
The FDA has approved Mycapssa® (octreotide; Chiasma) capsules for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.
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 has approved Fensolvi (leuprolide acetate; Tolmar Pharmaceuticals) for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
