"We think it's based on, you know, the overall data package we've been able to generate ... with the authorities toward approval in the EU." Welireg generated $139 million in sales during 2024 ...
The US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to include its use for the treatment of the rare cancer pheochromocytoma ...
GlobalData on MSN7d
MSD wins FDA priority review for Welireg in rare endocrine cancerThe US Food and Drug Administration (FDA) will soon decide on whether to expand the label of MSD’s Welireg (belzutifan) to ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral HIF-2α inhibitor, Welireg (belzutifan), for a new indication. The sNDA is ...
The proposal follows three years of research by agency scientists, who considered the front-of-package labels used by other countries. After reviewing studies on the effectiveness of those labels ...
About LITESPARK-015 LITESPARK-015 is an open-label, single-arm, multi-cohort Phase 2 trial (NCT04924075) evaluating the efficacy and safety of WELIREG monotherapy in patients with advanced PPGL ...
Grabbing a quick snack might soon come with a little extra clarity. The U.S. Food and Drug Administration (FDA) has proposed a new rule requiring bold, easy-to-read nutrition labels on the front ...
The US Food and Drug Administration (FDA) has taken a major step in addressing the nation’s chronic disease crisis by proposing a new front-of-package (FOP) nutrition label for most packaged foods.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback