30/10/2025 Lantheus received FDA PDUFA Date for LNTH-2501 (Ga 68 edotreotide), a PET Diagnostic Imaging Kit ( Ref ) The US FDA established a PDUFA date for Lantheus Holdings' LNTH-2501 (Gallium-68 edotreotide) diagnostic kit indicated for use with PET imaging for localization of SSTR+ neuroendocrine tumors in adult and pediatric patients. The FDA has set a PDUFA target action date of March 29, 2026 Brian Markison, CEO, Lantheus: “ The development of LNTH-2501 underscores our

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC ( Ref ) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab  entered a licensing agreement with JMT-Bio Technology (a wholly-

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma ( Ref ) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “ Receiving Rare Pediatric Disease Designatio

07/10/2025 Precision NeuroMed's cinetredekin besudotox received the FDA orphan drug designation for GBM ( Ref ) The US FDA granted the...

25/09/2025 Eli Lilly and Company's Inluriyo has been approved in the US for ER+, HER2–, ESR1-mutated breast cancer ( Ref ) The US FDA...

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

18/09/2025 Replimune completed a Type A meeting with the FDA to discuss the CRL for vusolimogene oderparepvec + nivo ( Ref ) Replimune...

15/09/2025 Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or...

08/09/2025 Beyond Air's BA-101 received the Orphan Drug Designation for GBM ( Ref ) The US FDA granted the Orphan Drug Designation to...

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML ( Ref ) The US FDA granted the Fast Track...

04/09/2025 Eli Lilly and Company's olomorasib in combination with Keytruda received the FDA Breakthrough Therapy designation...

03/09/2025 Boehringer Ingelheim's zongertinib received the FDA Breakthrough Therapy Designation for first-line HER2-mutant advanced NSCLC...

14/08/2025 Halda's HLD-0915 received the Fast Track Designation from the US FDA for mCRPC ( Ref ) The US FDA granted the Fast Track...

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

18/07/2025 ImCheck’s ICT01 received the Orphan Drug Designation for Acute Myeloid Leukemia ( Ref ) The US FDA granted the Orphan Drug...

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US ( Ref ) Shanghai Henlius Biotech announced...

April 3rd & 4th, 2025 Regulatory Updates   🎯 The UK MHRA granted conditional marketing authorization for  Autolus Therapeutics ’...

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