The agency narrowed who can get the shot and added new study requirements that could cost the company tens of millions.

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

The FDA has approved Merck’s Welireg (belzutifan), a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adults and pediatric patients aged 12 and older with locally advanced, ...

On the FDA’s docket this month are two expansion bids, one for GSK’s asthma drug Nucala into COPD and another for Merck’s ...

The advisory committee meeting is an important step in the process of readying boosters for the fall and winter season, but ...

Sanofi expands its U.S. manufacturing with a $20 billion investment. The FDA approves Merck's cancer drug for rare adrenal ...

The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck & Co. Inc.’s (NYSE:MRK) Welireg (belzutifan) for adult and pediatric patients 12 years and older with locally advanced ...

The U.S. Food and Drug Administration (FDA) on Wednesday approved Merck’s (NYSE:MRK) anti-cancer agent Welireg (belzutifan) as a treatment for rare neuroendocrine tumors, pheochromocytoma ...

Merck's Welireg wins FDA approval for rare PPGL tumors; Q1 2025 sales reach $137M, marking a 62% year-over-year increase.