09/10/2025 Adcendo's ADCE-D01 received the FDA fast track designation for the treatment of STS ( Ref ) The US FDA granted the fast track...

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 )...

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...

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

17/09/2025 Rgenta Therapeutics' RGT-61159 received the FDA Orphan Drug Designation for ACC ( Ref ) The US FDA granted the Orphan Drug...

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

11/09/2025 Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors ( Ref...

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer ( Ref ) The US FDA granted...

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...

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

20/08/2025 Invion's INV043 received the FDA's Orphan Drug Designation for anal cancer ( Ref ) The US FDA granted the Orphan Drug...

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...

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

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...

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...

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...

12/06/2025 MAIA Biotechnology and Roche announce a master clinical supply agreement for hard-to-treat cancer therapies ( Ref ) MAIA...