20/01/2026 In the Ph2b KN-942 trial, Moderna and Merck's intismeran autogene + pembro showed sustained RFS benefit at 5 years of median follow-up Lilly's sofetabart mipitecan received the FDA Breakthrough Therapy designation for platinum-resistant ovarian cancer Celcuity's NDA for gedatolisib has been accepted for priority review for advanced breast cancer Lantern Pharma's LP-284 received the FDA orphan drug designation for soft tissue sarcomas In the Ph2b KN-942 trial, Moder

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA ( Ref ) CARsgen Therapeutics submitted the New Drug...

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