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

The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have ...

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.

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 ...

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

Sunvozertinib received FDA priority review for NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy progression. The WU-KONG1 Part B study showed a 53.3% objective response ...

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

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on July 22, 2025. Shares of REPL were up 16.9% on Jan. 21 following the announcement of the news.

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 ...