FDA Grants Accelerated Approval for Qalsody (tofersen) for theTreatment of Amyotrophic Lateral Sclerosis Associated with a Mutationin the SOD1 Gene
April 25, 2023Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
April 26, 2023April 26, 2023 - Seres Therapeutics, Inc. and Nestlé Health Science have announced the U.S. Food and Drug Administration (FDA) approval of Vowst (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). Vowst is not indicated for the treatment of CDI.
Recurrent CDI represents significant unmet need and is a leading cause of hospital-acquired infection that can result in severe illness and death. Based on data from the U.S. Centers for Disease Control and Prevention (CDC), the companies estimate 156,000 episodes in the U.S. in 2023.
Seres and Nestlé Health Science are committed to helping appropriate patients who have been prescribed Vowst obtain access. Additional details about Vowst access programs will be available at launch.