The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...

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 ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

What is Cushing's syndrome? Cushing's syndrome is a hormonal disorder. It’s caused when you have high levels of the hormone cortisol over a long time. Cushing's syndrome is fairly rare. It most often ...

Viralgen and Axovia Therapeutics are partnering to develop and manufacture a gene therapy for the treatment of retinal ...

A pheochromocytoma is a type of tumor found in the adrenal glands or certain nerve cells. These tumors are very rare but can cause dramatic symptoms because they tend to secrete large amounts of ...

The panel of experts at the ISP felt strongly that localization of pheochromocytoma or paraganglioma should only be initiated if the clinical evidence for the presence of tumor is reasonably ...

Positron emission tomograph (coronal view) after intravenous injection of 6-[18 F]fluorodopamine. The patient had a small left adrenal pheochromocytoma. Approximately 6 months after removal of the ...