Introduction The MFDS clinical trial approvals in June 2025 provide valuable insight for domestic and international pharmaceutical and biotech professionals. During this one‑month period, Korea’s Ministry of Food and Drug Safety approved 14 investigational medical devices spanning AI‑based vital‑sign analysis…
Introduction: Korea as a Global R&D Hub The MFDS IND approval status is a critical barometer for pharmaceutical and biotech professionals planning research and development strategies. In June 2025, the Ministry of Food and Drug Safety (MFDS) approved 62 investigational…
“A Smart Approach to Accelerate Market Entry” Rare diseases affect only a small number of patients and offer limited treatment options. Developing orphan drugs for these conditions carries not only immense social value but also strategic importance. However, the development…