NLS Pharma Business

Lytix Biopharma has received FDA feedback on its proposed registrational Phase III trial design for ruxotemitide (LTX-315) in patients with resectable high-risk melanoma, with no objections raised – removing a key source of regulatory uncertainty as the company seeks a partner to fund and run the study.

The company has received an indicative offer for all shares in the company.

EMA has decided to grant  Orphan Drug Designation (ODD) for OXC-201 for idiopathic pulmonary fibrosis (IPF).

The US FDA has proposed reclassifying blue light cystoscopy (BLC) systems used with Photocure's imaging agent Cysview for bladder cancer detection from Class III to Class II, a move the Norwegian medtech company says will support wider adoption of the technology in US hospitals.

The European Commission has granted orphan drug designation to Lundbeck's investigational anti-ACTH monoclonal antibody asedebart for the treatment of endogenous Cushing's syndrome.

Norwegian microbiome diagnostics company Genetic Analysis has placed its GA-map Dysbiosis Test at the Centre for Digestive Diseases (CDD) in Sydney – the company's first placement in Australia and a new milestone in its international expansion.