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According to the applicant, the Selux NGP System received Breakthrough Device designation from FDA on September 21, 2021, with the indication that the Selux Positive Blood Culture Separator and Selux System is intended for use with bacteria separated from monomicrobial positive blood cultures and sterile body fluid culture samples from non-charcoal-containing types of BACTEC, BacT/ALERT, VIRTUO and VersaTREK blood culture bottles

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The 14 peptides remain Category 2 substances today and they are not currently eligible for routine 503A compounding despite certain public commentary

Injectable BPC-157, TB-500, and GH secretagogues explained with real protocols and timelines