Testing revealed that the product may have as low as 87% of the labeled amount of levothyroxine.
The effect of empagliflozin on all-cause mortality and hospitalization for heart failure will be evaluated in the in phase 3 EMPACT-MI study.
Detectnet (copper Cu 64 dotatate) is indicated for use with PET for localization of somatostatin receptor positive neuroendocrine tumors.
The approval was based on data from the randomized, double-blind, parallel-arm phase 3 AWARD-11 trial.
The multicenter, double-blind, placebo-controlled HAUSER-RCT study assessed the efficacy and safety of evolocumab in 157 patients aged 10 to 17 years with HeFH.
Mycapssa is an oral somatostatin analogue.
The post-hoc analysis included 2 placebo-controlled phase 3 studies (ORION-10 and -11) that evaluated the efficacy and safety of inclisiran sodium in more than 2300 adult patients.
The FDA concluded “the risk no longer meets the standard for a Boxed Warning.”
Vosoritide is an investigational analogue of C-type natriuretic peptide.
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
