Research & Development
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 ...
SK Biopharmaceuticals submits cenobamate supplemental New Drug Application to US FDA
5 November 2026 - SK Biopharmaceuticals Co Ltd, a South Korea-based pharmaceutical company, announced on Wednesday that it has submitted a supplemental New Drug Application (sNDA) to the US Food and D...