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

Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...

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

Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...

“Sunvozertinib’s priority review designation marks an important regulatory milestone in Dizal’s efforts to address unmet medical needs worldwide. The results from the WU-KONG1 Part B study are ...

identified by an FDA-approved test, the release states. The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with locally advanced ...

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

If approved, Sunvozertinib as a single oral drug would offer a convenient and safe treatment option with superior efficacy for NSCLC patients with EGFR exon20ins Sunvozertinib's NDA was submitted ...

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review ... In August 2021, the drug was first approved by the FDA for the treatment of a rare ...