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Lykos Therapeutics' new drug application for MDMA plus psychiatric intervention for adults with PTSD will be the first reviewed by an FDA committee for such a therapy.
Merck presented results from the STRIDE-10 phase 3 trial at the 34th European Society of Clinical Microbiology and Infectious Diseases in Barcelona, Spain.
FDA grants Priority Review for sNDA to convert FILSPARI® from accelerated approval to full approval for the treatment of IgAN in the U.S.; PDUFA target action date of September 5, 2024 Received 511...
Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations New real-world evidence shows Beyfortus substantially reduced RSV lower respiratory tract...
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.