Latest Regulatory Review News

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

Clarity Pharmaceuticals will present compelling data on its 64Cu-SAR-bisPSMA diagnostic agent at two leading oncology conferences, highlighting earlier and more accurate prostate cancer lesion detection than current standards.

Winsome Resources has taken a significant step forward in developing its Adina Lithium Project by submitting the Preliminary Information Statement to Quebec authorities, initiating a structured permitting process and enhancing stakeholder engagement.

Amcor plc has taken a pivotal step in its proposed merger with Berry Global by filing the definitive joint proxy statement with the SEC, setting the stage for shareholder votes in February. Integration planning is well underway as both companies prepare to unite their packaging expertise.