The FDA has accepted Merck's (MRK) supplemental NDA with priority review for its drug Welireg for the treatment of a rare ...

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

A Prescription Drug User Fee Act target date of May 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application ...

A Prescription Drug User Fee Act target date of May 26, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of 26 May 2025.

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 FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold ...

Lawson pointed to the potential FDA approval of RP1 as "increasingly de-risked" following the BLA acceptance and priority review. BMO Capital's Evan Seigerman also raised the price target to $27. ...