The approval was based on data from a Phase II trial, two retrospective chart review studies and an expanded access programme.

Merck Serono has failed to convince a US appeals court to overturn a PTAB decision invalidating two dosing regimen patents ...

Pharmacy benefit manager Prime Therapeutics is expanding its partnership with Sempre Health, a company that applies discounts at the pharmacy counter for people taking single-source drugs for chronic ...

FDA Approves KYGEVVI® (doxecitine and doxribtimine), the First and Only Treatment for Adults and Children Living with Thymidine Kinase 2 deficiency (TK2d), a Rare and Devastating Mitochondrial Disease ...

The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

The Food and Drug Administration has designated Celltrion’s Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to Prolia and Xgeva, respectively, for all approved ...