30/09/2025 Umoja Biopharma's UB-VV111 in vivo CAR T cell therapy received the FDA fast track designation for B-Cell Malignancies ( Ref )...

September 3rd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co/ MSD ’s Keytruda Qlex (subcutaneous injection of...

22/07/2025 Replimune's BLA for vusolimogene oderparepvec + nivo received a CRL from the US FDA ( Ref ) The US FDA issued a Complete...

📢 The U.S. FDA launched a new program - the Commissioner’s National Priority Voucher (CNPV) - to shorten review timelines from 10-12...