Research & Development
Ascletis announces submission of US IND application for oral obesity combination therapy
11 November 2026 - Biotechnology company Ascletis Pharma Inc (HKEX: 1672) reported on Wednesday that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administrati...
Abbisko Therapeutics' PIMJETMI receives US FDA approval to treat tenosynovial giant cell tumour (TGCT)
11 November 2026 - Abbisko Therapeutics Co Ltd (HKEX code: 02256.HK), a China-based biopharmaceutical company, announced on Tuesday that the US Food and Drug Administration (FDA) has approved PIMJETMI...
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...