21/01/2026 BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 Wugen's soficabtagene geleucel received the FDA Breakthrough Therapy Designation for T cell malignancies Opna Bio's zavabresib received the FDA orphan drug designation for myelofibrosis BioNTech's BNT113 + pembro received the FDA fast track designation for HPV16+ R/M SCCHN with PD-L1 CPS ≥1 ( Ref ) The US FDA granted the fast track designation to BioNTech's BNT

29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 ( Ref ) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on res

19/09/2025 Merck & Co/MSD received positive EU CHMP Opinions for perioperative pembrolizumab regimen in SCCHN, and for subcutaneous...

Highlights from the CHMP Sep 2025 Meeting are out! New Biosimilars 💊  Teva Pharmaceuticals ' Degevma (RANKL inhibitor; denosumab...

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...

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

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

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

30/07/2025 Phase 3 COSTAR Lung trial of dostarlimab + docetaxel ± cobolimab failed to meet the OS endpoint in previously treated NSCLC (...

11/07/2025 Cel-Sci to partner with a leading Saudi Arabian pharma company for Multikine in the Tx of Head & Neck Cancer ( Ref ) Cel-Sci...

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC ( Ref ) The EC approved BeOne Medicines'...

19/06/2025 Initial patient screening completed in Transgene's Phase 2 trial of TG4050 vaccine in resectable SCCHN ( Ref ) Transgene...

29/04/2025 ALX Oncology’s Phase 2 ASPEN-03 & ASPEN-04 trials failed to meet the primary endpoint of ORR ( Ref 1 ) ALX Oncology hit with a...