FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment …
Dec 15, 2023 · The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. Verify pregnancy status prior to the initiation of WELIREG. Advise patients of these risks and the need for effective non-hormonal contraception.
FDA approves belzutifan for advanced renal cell carcinoma
On December 14, 2023, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) for patients with advanced renal cell carcinoma (RCC) following a programmed death...
On blockbuster mission, Merck says Welireg hit endpoint in renal …
Aug 18, 2023 · Two years after Welireg's original approval in the rare von Hippel-Lindau (VHL) disease, Merck is looking to expand its drug's reach and turn it into a blockbuster.
FDA Approves New Treatment for Advanced Kidney Cancer
Dec 18, 2023 · The December 14 decision marks the first approval of a new class of therapy for advanced renal cell carcinoma (RCC), the most common type of kidney cancer, in nearly a decade. Welirig is a hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, a type of targeted therapy.
FDA approves belzutifan for advanced renal cell carcinoma
Dec 15, 2023 · The FDA has approved belzutifan (Welireg) for the treatment of patients with advanced renal cell carcinoma (RCC) who have progressed following treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI, announced Merck, the developer of the drug, in a news release. 1
Merck's Welireg becomes first drug for rare VHL tumours in US
Aug 16, 2021 · Welireg (belzutifan), an oral HIF-2 alpha inhibitor, has been approved by the FDA for adults with von Hippel-Lindau (VHL) disease, an inherited condition caused by a mutation in the VHL gene that...
FDA Approves Merck’s WELIREG® (belzutifan) for the ... - Nasdaq
Dec 15, 2023 · Merck, known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration has approved WELIREG, an oral hypoxia-inducible factor-2 alpha inhibitor ...
MSD’s Welireg secures FDA approval for renal cell carcinoma
Dec 15, 2023 · Merck (MSD) has secured US Food and Drug Administration (FDA) approval for Welireg (belzutifan), indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
FDA signs off on a second approval for Merck's Welireg - Fierce …
Dec 15, 2023 · The U.S. regulator has given a thumbs up for Welireg to treat relapsed or refractory renal cell carcinoma (RCC) for adult patients who have not responded to a PD-1 or PD-L1 inhibitor and...
FDA Accepts for Priority Review Merck’s Supplemental New Drug ...
Sep 19, 2023 · WELIREG (belzutifan) is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system...