Research & Development
bioMérieux secures FDA clearance and IVDR CE marking for VITEK PRO diagnostic platform
10 November 2026 - French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Tuesday that it has received US Food and Drug Administration (FDA) 510(k) clearance and European IVDR ...
Compass Pathways completes FDA application for COMP360 in treatment-resistant depression
9 November 2026 - Biotechnology company Compass Pathways plc (Nasdaq:CMPS) said on Monday that it has completed its New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) f...
bioMérieux secures FDA clearance for updated gastrointestinal diagnostic panels
9 November 2026 - French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Monday that it has received US Food and Drug Administration (FDA) 510(k) clearance for its BIOFIRE FILM...
Photocure maintains 2028 Medicare coverage target for AssureMDx following CMS update
9 November 2026 - Diagnostic company Photocure ASA (OSE: PHO) confirmed on Monday that the anticipated Medicare coverage timeline for its AssureMDx bladder cancer test remains aligned with its origina...
RYBREVANT FASPRO co-formulated with Halozyme's ENHANZE technology approved by US FDA in advanced head and neck cancer
9 November 2026 - Biotechnology company Halozyme Therapeutics Inc (Nasdaq:HALO) announced on Friday that Johnson & Johnson (NYSE:JNJ) was granted accelerated approval from the US Food and Drug Adm...
Johnson & Johnson reveals new Phase 2 nipocalimab study data in Sjögren's disease
9 November 2026 - Healthcare company Johnson & Johnson (NYSE:JNJ) on Saturday reported new patient experience findings from the Phase 2 DAHLIAS study of nipocalimab in Sjögren's disease ...