Company

Product

Description

Indication

Status

Cormedix Inc., of Berkeley Heights, N.J.

Neutrolin

Non-antibiotic antimicrobial solution

Hemodialysis

Completed interaction with FDA related to CMC package to support NDA; pre-NDA meeting now scheduled

Denovo Biopharma LLC, of San Diego

DB-102

Inhibits protein kinase C beta

Newly diagnosed glioblastoma

FDA cleared start of phase IIb trial in combination with radiation and temozolomide

Proqr Therapeutics NV, of Leiden, the Netherlands

Sepofarsen

RNA-based oligonucleotide

Leber's congenital amaurosis 10

Received rare pediatric disease designation from FDA

Notes

For more information about individual companies and/or products, see Cortellis.

 

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