Presence of Glass Particles Prompts Recall of Octreotide Acetate Injection
To date, the Company has not received any reports of adverse reactions related to this recall.
To date, the Company has not received any reports of adverse reactions related to this recall.
Xeris Biopharma has established Xeris CareConnection™, a comprehensive support program.
Pfizer is evaluating the FDA’s comments in the CRL and will work with the Agency to determine the appropriate steps forward.
The approval was based on data from two phase 3 studies that evaluated Recorlev in 166 adults with endogenous Cushing syndrome.
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.