The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for SL1009 (sodium dichloroacetate oral solution) for the treatment of pyruvate dehydrogenase complex ...

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

The FDA has accepted Merck's (NYSE:MRK) supplemental New Drug Application with priority review for its drug Welireg, also known as belzutifan, for the treatment of a rare type of adrenal gland tumors.

Leerink Partners analyst Jonathan Chang has reiterated their bullish stance on REPL stock, giving a Buy rating yesterday.Invest with ...

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.

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 ...

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 ...

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. ...

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 ...

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