"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 ...
The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.
Readers had a lot to say about my latest column on the Food and Drug Administration’s proposed front-of-package labels. Most ...
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 ...
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 ...
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 (Cohort A1), pNETs (Cohort ...
The updated definition will reflect those changes. The FDA is also testing new front-of-package labels to help consumers quickly identify whether a product meets the new health standards.
6 See University of North Carolina-Chapel Hill, “Front-of-Package Labels Around the World,” Global Food Resource Program (2023), GFRP-UNC_FOPL_maps_2023_02.pdf (accessed Jan. 27, 2025).
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