GlobalData on MSN6d
MSD wins FDA priority review for Welireg in rare endocrine cancer
The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...
The Pharma Letter6d
Merck’s Welireg sNDA accepted for priority review in PPGL
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...
PharmiWeb6d
FDA Grants Priority Review to Merck’s Application…
Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL If approved, WELIREG would be the only available therapy ...
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 ...