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

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

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...

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...

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

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

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

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