Regulatory
Finally, Pfizer has submitted the request to FDA to grant emergency use status to their vaccine for children. Here’s everything you should know about the vaccine.
Details about the U.S. government’s contract with Pfizer for 10 million doses of Paxlovid are emerging, with some unusual elements.
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.
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