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Nobelpharma America has become the first company to win FDA approval for a topical treatment for facial angiofibroma associated with tuberous sclerosis complex (TSC).
Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, defended the agency's rejection of Eli Lilly and Innovent Biologics' PD-1 inhibitor. The U.S.
After the FDA snubbed Eli Lilly and Innovent Biologics’ cancer immunotherapy sintilimab because of China-only data, all eyes have turned to the next China-developed PD-1 therapy in line at the FDA.