The FDA granted accelerated approval to Gilead Sciences’ Hepcludex (bulevirtide-gmod).
Hepcludex is the first and only U.S.-approved therapy for adults with chronic hepatitis delta virus (HDV).
The European Medicines Agency's CHMP also issued a positive opinion for Trodelvy as a monotherapy.
This recommendation targets adults with specific metastatic triple-negative breast cancer.
Gilead shares rose 3% on May 22 following these regulatory developments.