Astellas Pharma Inc. (OTC:ALPMY) said today that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Fezolinetant, an oral, non-hormonal compound that is being tested to treat moderate to severe vasomotor symptoms (VMS) caused by menopause. Symptoms of menopause often include VMS, which is marked by hot flashes and/or night sweats. 1,2
After using a priority review voucher, the PDUFA target action date is February 22, 2023. (PRV). Astellas's (OTC:ALPMY) R&D spend for the first quarter of fiscal year 2022 was comprised of 13,1 billion of PRV-related intangible asset ...
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U.S. FDA Accepts Fezolinetant New Drug Application from Astellas