Good News For Immunomedics' Triple Negative Breast Cancer Trial
A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.
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Keeping Track Of Approvals: US FDA Keeps Up Fast Pace In Oncology With Early Nods For Trodelvy, Pemazyre
The latest US FDA product approval news from the Pink Sheet FDA Performance Tracker.
Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.
Pembrolizumab should be considered the new standard of care as first-line therapy in patients with microsatellite instability high (MSI-H) metastatic colorectal cancer, KEYNOTE-177 investigator André said.