phase III clinical study
Spur Therapeutics, FDA Align on Phase III Plans for Gaucher Disease Gene Therapy
The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.
AstraZeneca, Daiichi Sankyo Begin Phase III Trial of Datroway in High-Risk Early-Stage NSCLC
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.
Opdivo, Yervoy Outperform Single-Agent Immunotherapy in First-Line MSI-High, dMMR Colorectal Cancer
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Data presented at the ASCO Gastrointestinal Cancers Symposium showed the regimen may be a new option, but it comes with more treatment and financial toxicity.
ITM Eyes Regulatory Filing Following Positive Top-Line Readout in GEP-NETs
Patients on the firm's SSTR-targeted radiopharmaceutical had improved progression-free survival compared to patients on an mTor inhibitor in a Phase III trial.