Indivior (INDV) provided the following update regarding its PDUFA action date for label changes for Sublocade Injection, which was scheduled ...

The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...

Navigating regulatory hurdles in the U.S. and Europe, plus fierce competition from rival Apellis, Astellas’ geographic ...

February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart ...

the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) nutrition labeling (“proposed rule”). 1 If finalized, the ...

Renu Lal, Pharm.D., is Scientist, Genentech, Inc.; when this article was written she was Team Leader, Division of Drug Information, Office of Training and Communications, Center for Drug ...

C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...

The Food and Drug Administration announced it would decide by April 2024 whether chemical hair straightening products sold in the U.S. would be banned from using formaldehyde or ingredients that ...

The executive order, which Trump signed Monday, is intended to apply maximum pressure on Mexico to rein in its dangerous drug trade ... The terrorist label could also push big parts of Mexico ...

Initially approved in 2019 for use alongside oral antidepressants, this label expansion follows a priority review from the FDA. The approval was based on data from the Phase IV TRD4005 study ...

The nasal spray Spravato, which is made from the drug esketamine, had been approved in 2019 for patients who failed to respond to at least two oral antidepressants. However, it had to be used in ...