After CRL, CorMedix says new filing has been accepted by FDA; Spine BioPharma nets a modest Series B
After a manufacturing slip-up led to a CRL last year, a small biotech says its new approach is ready for the FDA.
NJ-based CorMedix refiled its application for its antibacterial and antifungal treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, the company announced Monday. The FDA has accepted the filing, considers it a “Class 2 response” and will look at it as part of a six-month review, CorMedix added.
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