Regulatory
Recent FDA approval of ViiV Healthcare’s HIV treatment Cabenuva reduced dosing to once every two months.
Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, NVX-CoV2373, a protein-based vaccine.
Altimmune announced Monday that the U.S. Food and Drug Administration (FDA) has approved a Phase II clinical trial for investigational new obesity drug pemvidutide.
Eli Lilly and Company announced that it was discontinuing the Phase III development program for Olumiant (baricitinib) in lupus.
The resubmission follows a Type B pre-BLA resubmission meeting with the US Food and Drug Administration (FDA).
The FDA had accepted the sBLA in September 2021 under priority review status.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Americans pay the highest drug prices in the world while importing drugs for lower prices from other countries has been locked down on a personal level and labeled as “unsafe.”
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.
PRESS RELEASES