August 12, 2024
Action The U.S. Food and Drug Administration has approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism. Yorvipath was not studied in adults with […]
August 12, 2024
What is heartburn? Heartburn occurs when stomach contents flow back up into the esophagus—the muscular tube that carries food and liquids from the mouth to the […]
August 12, 2024
The US Food and Drug Administration (FDA) has approved palopegteriparatide (Yorvipath) for the treatment of hypoparathyroidism in adults, the drug’s manufacturer Ascendis Pharma announced. In hypoparathyroidism, […]
August 12, 2024
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
August 12, 2024
In 2020, CDER’s Office of Generic Drugs (OGD) and several partner researchers quantified the effect of drug solubility and partition coefficient on the dissolution and subsequent […]
August 12, 2024
Pharmacometric Models as Tools in Drug Development and Review Pharmacokinetic (PK) models are increasingly relied upon in drug development and review. Typically consisting of a set […]
August 12, 2024
CDER researchers and collaborators at NCTR are developing pharmacometric models that can support software tools that can be used by clinicians to guide drug dosing for […]
August 12, 2024
Over the past decade, progress has been made in planning and conducting clinical trials for rare disease drug development. In 2018, for the first time ever, […]
August 12, 2024
TOPLINE: A novel method combining genetic variants, symptoms, and patient characteristics is moderately successful at predicting which primary care patients are at high risk of developing […]