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 ...

The Food and Drug Administration (FDA) has granted Priority Review to nipocalimab for the treatment of generalized myasthenia gravis (gMG) in antibody positive (eg, anti-acetylcholine receptor, ...

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 ...

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.

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 ...

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 ...

Member FDIC Read our Southwest Rapid Rewards® Priority Credit Card review. The Southwest Rapid Rewards® Priority Credit Card is a perfect fit for serious Southwest fans who can easily maximize ...

Please provide your email address to receive an email when new articles are posted on . The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain ...

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025. The FDA granted priority review to a supplemental new ...

The FDA granted priority review to datopotamab deruxtecan in advanced EGFR-mutated NSCLC after prior therapies, with a decision expected by July 12, 2025. The FDA has accepted and granted priority ...