16/09/2025 Corbus and CSPC Pharma's CRB-701 ADC received the FDA Fast Track Designation for R/M HNSCC ( Ref ) The US FDA granted the Fast...

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...

29/08/2025 BeOne reported positive topline results for sonrotoclax in R/R MCL ( Ref ) BeOne Medicines' Phase 1/2 BGB-11417-201 trial of...

28/08/2025 TOLREMO Therapeutics' TT125-802 received two fast track designations from the US FDA for NSCLC ( Ref ) The US FDA granted two...

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer ( Ref )...

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...

13/08/2025 Merck's perioperative Keytruda regimen received approval in Canada for resectable HNSCC with PD-L1 CPS ≥1 ( Ref ) Health...

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC ( Ref )...

11/08/2025 IO Biotech's Cylembio + pembrolizumab demonstrated clinical improvement in PFS as a first-line treatment of Melanoma, but...

08/08/2025 Boehringer Ingelheim's Hernexeos received accelerated approval from the US FDA for HER2-mutant advanced NSCLC ( Ref ) The US...

07/08/2025 ProteinQure's PQ203 received the Fast track designation for TNBC ( Ref ) The US FDA granted the Fast Track designation to...

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN ( Ref ) Immutep...

04/08/2025 Alphamab's IND application for JSKN022 was accepted by China's CDE ( Ref ) Alphamab Oncology's IND application for JSKN022...

31/07/2025 MaxCyte and Anocca AB signed a Strategic Platform Licensing Agreement to advance TCR-T cell therapies ( Ref ) MaxCyte signed a...

29/07/2025 Calidi Biotherapeutics' CLD-201 received the US FDA Fast Track Designation for soft tissue sarcoma ( Ref ) The US FDA granted...

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