The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...
“PPGL includes all of these tumours; they can arise anywhere from the base of the skull down to the bladder.” As PPGLs are rare, obtaining evidence to prove the safety and efficacy of a ...
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
Rahway, New Jersey Tuesday, January 28, 2025, 10:00 Hrs [IST] ...
Imaging studies did not localise any phaeochromocytoma or paraganglioma (PPGL). Repeat biochemical testing after discharge was within normal limits in both cases. These observations suggest that ...
PPGL is a group of rare neuroendocrine tumours originating from adrenal gland tissue or paraganglia. Credit: Witthaya Prasongsin via Getty Images. The US Food and Drug Administration (FDA) will soon ...
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