Announced on May 1, the CRL from the FDA expressed concerns related to manufacturing control strategy, but did not express concern related to clinical data submitted as part of the NDA package for TransCon PTH.
Those with ≥67% of albumin-corrected serum calcium measurements outside of the study-defined limits had 1.9-fold higher odds of experiencing a cardiovascular event compared with patients with <33% of calcium measurements outside the range.
Leveraging data from more than 40,000 Veterans with primary hyperparathyroidism, a new NIA-funded study details the impact of parathyroidectomy on long-term kidney function among these patients.