02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma ( Ref ) The US FDA granted...

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...

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

09/09/2025 Johnson & Johnson's INLEXZO received US FDA approval for NMIBC ( Ref ) The US FDA approved Johnson & Johnson's INLEXZO™...

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 (...

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

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

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

07/07/2025 SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC ( Ref ) The US FDA approved Sirtex Medical's SIR-Spheres...

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma ( Ref ) Regeneron Pharmaceuticals announced...

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