Cure Today3d
FDA Accepts sNDA for Welireg in Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...
Targeted Oncology4d
FDA Grants Belzutifan Priority Review For Advanced 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.
Zacks.com on MSN4d
MRK's sNDA for Welireg in Rare Tumors Gets FDA's Priority Tag
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...
thecardiologyadvisor.com4d
FDA Extends Review of Elamipretide for Barth Syndrome
The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.
Endocrinology Advisor5d
Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
D.C.'s Vanda Pharmaceuticals battling FDA on multiple fronts
A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic ...
Pharm Exec5d
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...
Pharmaceutical Technology5d
Eisai and Biogen’s Leqembi sBLA set for Alzheimer’s maintenance dosing
The FDA has approved the sBLA of Eisai and Biogen's LEQEMBI for maintenance dosing indicated for the early stages of ...
Merck gets priority review for Welireg for PPGL
The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...
Contract Pharma5d
Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
BioArctic: FDA approves IV maintenance dosing of Leqembi (lecanemab-irmb) for the treatment of early Alzheimer's Disease in the US
BioArctic AB (publ) (NASDAQ STOCKHOLM: BIOA B) today announced that the U.S. Food and Drug Administration (FDA) has approved BioArctic's partner Eisai's ...