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

This rising trend mirrors the evolution of the pharmaceutical industry in terms of investment and utilisation of novel ...

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...

The FDA has extended the review period for the New Drug Application for elamipretide for the treatment of Barth syndrome.

The regulatory agency will review MSD’s new drug application (NDA) for Welireg under a Priority Review, with a Prescription ...

Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...

Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug ...

The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a ...

The agencies are charged with making decisions that touch the lives of every American and are the source of crucial ...