FDA Denies Approval of Long-Acting Pediatric Growth Hormone Therapy
Pfizer is evaluating the FDA’s comments in the CRL and will work with the Agency to determine the appropriate steps forward.
Endocrine Disorders
Insulin Prefilled Pens Recalled Due to Missing Label
The recall does not pertain to the interchangeable biosimilars, Semglee (insulin glargine-yfgn) injection, or Insulin Glargine (insulin glargine-yfgn) injection.
Hydrocortisone Rescue Pen Fast Tracked for Adrenal Insufficiency
ATRS-1902 is an investigational rescue treatment that uses a proprietary autoinjector to deliver a liquid stable formulation of hydrocortisone.
Comprehensive Approach Advised for Managing CV Risk in T2DM
In addition to managing all cardiovascular risk factors, providers must consider social determinants of health
ADA Updates Standards of Medical Care in Diabetes for 2022
Updates include recommendation to screen for prediabetes and diabetes in all people starting at age 35 years
Packaging Update Announced for Rybelsus Tablets
The Company is transitioning away from the blister packs to fully recyclable 30-count bottles.
Inequities Seen in GLP-1 RA Use for Type 2 Diabetes in the US
Asian, Black, Hispanic, and low-income patients less likely to receive treatment with a glucagon-like peptide-1 receptor agonist for T2DM
Recorlev Approved to Treat Endogenous Hypercortisolemia in Cushing Syndrome
The approval was based on data from two phase 3 studies that evaluated Recorlev in 166 adults with endogenous Cushing syndrome.
FDA Approves Biosimilar Insulin Product Rezvoglar
Rezvoglar is a long-acting human insulin analogue.
USPSTF: Evidence Lacking for T2DM Screening in Children
Current evidence is inadequate for assessing benefits and harms of type 2 diabetes screening in children and adolescents
