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

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 ...

For five years now, a bipartisan group of Illinois lawmakers have wanted to establish a Prescription Drug Affordability Board ...

"We need to know what adverse events are. We need to understand the safety of every drug, mifepristone, and every other drug.

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 US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial ...

The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.

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

The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...

The U.S. Food and Drug Administration formally authorized Zyn nicotine pouches for sale after conducting an "extensive ...