Invion Limited has affirmed its compliance with ASX disclosure rules following the US FDA’s granting of Orphan Drug Designation for its anal cancer treatment candidate INV043. The company detailed the timing and verification process behind its announcement.
EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.
