01/12/2025 Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia ( Ref ) The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL ( Ref ) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D

24/11/2025 Avenzo Therapeutics' AVZO-103 received the FDA fast track designation for metastatic urothelial cancer ( Ref ) The US FDA granted the fast track desingation to Avenzo Therapeutics' AVZO-103 (Nectin4/TROP2 bispecific antibody-drug conjugate) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer, Avenzo Therapeutics: “ Rece

23/11/2025 NovelWise's NBM-BMX received the FDA orphan drug designation for uveal melanoma ( Ref ) The US FDA granted the orphan drug designation to NovelWise Pharmaceutical Corporation's NBM-BMX (selective HDAC8 inhibitor) for the treatment of uveal melanoma. John Soong, MD, Chief Executive Officer, NovelWise: “ Receiving both Fast Track Designation and now Orphan Drug Designation underscores NBM-BMX’s promise in addressing a high unmet medical need for patients with uveal m

20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC ( Ref ) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based

18/11/2025 AbbVie and Genmab's epcoritamab + rituximab + lenalidomide received FDA approval for R/R FL ( Ref ) The US FDA granted approval to AbbVie and Genmab's epcoritamab (bispecific CD20-directed CD3 T-cell engager) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).  The approval is based on results from the Phase 3 EPCORE FL-1 trial of the combo vs rituximab and lenalidomide Lorenzo Falchi, M.D.,

13/11/2025 Kura Oncology and Kyowa Kirin's ziftomenib received FDA approval for certain R/R AML pts ( Ref ) The US FDA granted full approval to Kura Oncology and Kyowa Kirin's ziftomenib (KOMZIFTI™; menin inhibitor) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.  Troy Wilson, President and CEO, Kura Oncology: “ KOMZIFTI combines compelling efficacy, a fa

11/11/2025 Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL ( Ref ) The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Yan Moore, CEO, Allterum Therapeutics: " The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and fami

03/11/2025 Iovance's lifileucel TIL therapy elicited an ORR of 25.6% in previously treated non-sq NSCLC ( Ref ) Iovance Biotherapeutics reported interim data from its registrational Phase 2 IOV-LUN-202/NCT04614103 trial of lifileucel monotherapy (autologous TIL therapy) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. An ORR of 25.6% (CR: 5.1%) was achieved in a pool of 39 patients At a median follow up of 25.4 mos, the mDO

27/10/2025 Cellectar Biosciences' iopofosine I131 received the rare pediatric drug designation for pediatric high-grade glioma ( Ref ) The US FDA granted the rare pediatric drug designation (RPDD) to Cellectar Biosciences' iopofosine I131 in inoperable R/R pediatric high-grade glioma (pHGG). The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG James Caruso, President and CEO, Cellectar: “ Receiving Rare Pediatric Disease Designatio

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...

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

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

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...

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

21/08/2025 In a $350M deal, Kite to acquire Interius BioTherapeutics ( Ref ) Kite (a Gilead Company) entered into a definitive agreement...

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

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...