FDA News

Aprocitentan is the first-and-only dual endothelin receptor antagonist approved for the treatment of systemic hypertension.

The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.

The FDA cleared Novavax to start enrolling the planned phase 3 trial after a safety concern was found to be unrelated to the combination vaccine.

Your daily dose of the clinical news you may have missed.

Oral sulopenem is the first oral penem approved in the US for treating uUTIs in women with limited options.

Pfizer announced the FDA approval on October 22 that makes Abrysvo now the RSV immunization with the broadest indication for adults, the company said.

The safety data used to update the Flublok label is from a study of more than 48 000 pregnant women across multiple flu seasons, according to Sanofi.

The FDA today accepted GSK's NDA for gepotidacin for the treatment of uncomplicated urinary tract infections in women and adolescents.

Your daily dose of the clinical news you may have missed.

Update: The FDA has told compounding pharmacies they may resume production of tirzepatide products while the agency further investigates supply.