Regulatory
Gilead Sciences revealed in a call with analysts that the hold has now been expanded to additional magrolimab studies.
Shares of LogicBio Therapeutics have fallen more than 57% this morning after the company announced that its gene therapy for pediatric patients with methylmalonic acidemia has been placed on clinical hold by the U.S. Food and Drug Administration.
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.
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