FDA Grants IND Status To Clinuvel's Photoprotective Afamelanotide (Medical News Today)
Melbourne-based Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained Investigational New Drug (IND) status for its photoprotective drug afamelanotide from the US Food and Drug Administration (FDA). Clinuvel can now commence clinical trials in the US, the world's largest pharmaceutical market.

AdvanDx Receives FDA 510(k) Clearance For E. Coli/P. Aeruginosa PNA FISH(R) (Medical News Today)
AdvanDx announced it received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH(R) to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures. E. coli/P. aeruginosa PNA FISH is the first-ever test for identifying E. coli and P.