Astellas Pharma Inc. announced on Jan 4, 2024, the FDA issued a complete response to their zolbetuximab Biologics License Application.

Concomitant medication refers to the drugs that the subjects take at the same time as the trial drugs in clinical trials.

Medison Pharma and Regeneron Ireland DAC have formed an exclusive partnership for Medison to distribute Regeneron's innovative treatment, Libtayo® (cemiplimab).

Harbour Biomed and its subsidiary Nona Biosciences have entered an exclusive deal with Pfizer for the global development and commercialization of their anti-mesothelin ADC, HBM9033.

Lutikizumab Demonstrates Encouraging Outcomes in Phase 2 Study Among Individuals with Moderate to Advanced Hidradenitis Suppurativa, Progressing to Next Trial Stage.

The data management process involves system setup, CRF/database creation, data collection/entry, validation/querying, medical coding, handling external data, blind reviews, database locking, data export/exchange, and archiving documentation.

The CDE recently accepted Innovent Biologics and GenFleet Therapeutics' joint NDA for GF-105, prioritizing its review for advanced NSCLC patients with the KRAS G12C mutation after first-line therapy.

The latest clinical findings of Igrelimogene litadenorepvec were unveiled at the 2023 ESMO_IO, demonstrating its potential benefit and setting the stage for subsequent investigations.

Innovent declared the successful completion of the initial stage 3 clinical evaluation for Mazdutide among overweight and obese adults in China.

Run in period and washout period are two commonly used concepts in clinical trials.

The EU Commission has approved Eylea™ 8 mg, an 8 mg aflibercept (114.3 mg/ml) injectable, for treating neovascular age-related macular degeneration and diabetic macular edema-related vision loss.

Abbisko Therapeutics entered into an exclusive license deal with Merck, Germany, for its CSF-1R inhibitor, Pimicotinib (ABSK021).