PolyPid Announces FDA Acceptance Of Its New Drug Application With A Priority Review For D-PLEX100 For The Prevention Of Surgical Site Infections In Patients Undergoing Abdominal Colorectal Surgery; PDUFA Action Date Is November 28
The FDA did not identify any filing review issues and set a Prescription Drug User Fee Act ("PDUFA") target action date of November 28, 2026, approximately one quarter ahead of the Company’s previously
PolyPid's new medicine for preventing infections after belly surgery passed the FDA's first check and will get a decision by late November 2026. This is a good sign the medicine might become available, so watch if the company hits its testing goals and what doctors think about it.
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