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Your source for insights on emerging trends and regulatory updates shaping pharmaceutical manufacturing this week.

FDA issues Complete Response Letter to Cyprium / Sentynl over CUTX-101 for Menkes disease

The FDA has declined approval of the copper histidinate product CUTX-101 for the treatment of Menkes disease, issuing a Complete Response Letter due to manufacturing deficiencies, not necessarily efficacy or safety concerns.

Oct 2, 2025

FDA accepts sBLA for T-DXd + THP in high-risk HER2+ early breast cancer

The FDA has accepted a supplemental Biologics License Application (sBLA) to evaluate neoadjuvant fam-trastuzumab deruxtecan (T-DXd) followed by THP (trastuzumab + pertuzumab + docetaxel) in high-risk, early-stage HER2-positive patients.
This move may expand the use of T-DXd beyond metastatic disease into the curative/neoadjuvant setting.

Oct 2, 2025

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