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.
Tirosint-SOL is approved for the treatment of hypothyroidism and for pituitary thyrotropin suppression.
By scanning the glucose sensor with the app, users will be able to receive their current glucose level, trend arrow, and glucose history.
Semglee (insulin glargine) may be substituted for the reference product, Lantus, at the pharmacy counter and without the intervention of the prescriber.
Nevro’s SCS system for painful diabetic neuropathy will be available under the brand name HFX™ for PDN.
The approval was based on data from the phase 3 FIDELIO-DKD trial.
Teplizumab is an investigational anti-CD3 monoclonal antibody.
BBP-631 is an adeno-associated virus 5 (AAV5) gene therapy designed to deliver a functional copy of the 21-hydroxylase gene to restore the body’s ability to produce cortisol and aldosterone.
The NDA submission includes data from the phase 3 SONICS and LOGICS studies that evaluated levoketoconazole in adults with endogenous Cushing syndrome.
