![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » EMA Committee Recommends Eight Medicines for Approval
EMA Committee Recommends Eight Medicines for Approval
![EMA_Logo.gif](https://www.fdanews.com/ext/resources/test/Drug-Images3/EMA_Logo.gif?t=1579219264&width=430)
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars.
The two biosimilars are Amgen products: Solimbic, for treating psoriatic arthritis, Crohn’s disease, and ulcerative colitis, among other conditions; and Amgevita, known as Amjevita in the U.S., for the treatment of rheumatoid arthritis and other inflammatory diseases.
The expert committee also issued a positive opinion on a hybrid application for Therakind’s Jylamvo for treatment of acute lymphoblastic leukemia, severe psoriasis and arthritis. Hybrid applications rely in part on data for a reference product and in part on new data.
Upcoming Events
-
21Oct