Latest Fda Communications News

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.

Mayne Pharma has voluntarily withdrawn a speaker presentation for its contraceptive NEXTSTELLIS® following an FDA Untitled Letter concerning promotional claims. The company confirms this does not impact sales or its planned merger with Cosette.

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.