Bio News

The Ministry of Food and Drug Safety revised its new drug approval and review procedures to support the goal of approval within 240 days. The revision follows the innovation measures announced in May and centers on omitting some procedures when drugs are designated as orphan drugs and clarifying Pre-NDA meetings. The MFDS expects the changes to improve predictability for the industry, accelerate new drug approvals and bring treatment opportunities to patients sooner.

BIOBOOK TEAM
biobookmedia@biobook.co.krParagon Spin-Off Velaris Goes Public Through Reverse Merger With Alaunos
Syndax halts development of Niktimvo for pulmonary fibrosis; shares plunge 17%
BioNTech’s mRNA Cancer Vaccine Misses Primary Endpoint for Progression-Free Survival in Phase 3 Trial
Roche Signs $1.6 Billion Deal With China’s Rona for ALK7 Obesity Drug
Formycon and Zydus’ Keytruda Biosimilar Is First to Be Accepted for FDA Review
Pfizer Signs $500 Million Protein Degrader Deal With Enodia