Regulatory

Regulatory  ·  Weekly Digest - 06 December to 12 December 2025
OBI-902 receives consecutive FDA Orphan Drug Designation indication expanded to gastric cancer including gastroesophageal junction adenocarcinoma

Weekly Digest – December 2025 Weekly Digest – December 2025 05 December 2025: OBI-902 receives consecutive FDA Orphan Drug Designation indication expanded to gastric cancer including gastroesophageal junction adenocarcinoma OBI Pharma has received a major boost in its oncology pipeline, […]

by Sandhya Ramalingam

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Regulatory  ·  Weekly Digest - 06 December to 12 December 2025
GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA

Weekly Digest – December 2025 Weekly Digest – December 2025 10 December 2025: GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA GSK’s B7-H3–targeted antibody-drug conjugate, Risvutatug rezetecan (GSK’227), has gained fresh […]

by Sandhya Ramalingam

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