23/02/2026 Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer RYBREVANT SC received EC approval for Q3W and Q4W dosing for EGFR-mutated NSCLC Artios Pharma's ART6043 + olaparib received the FDA fast track designation for breast cancer ( Ref ) The US FDA granted the Fast Track designation to Artios Pharma's ART6043 (DNA polymerase theta (Polθ) inhibitor) + olaparib (PARP inhibitor) for the treatment of adult patients with germline BRCA

17/02/2026 Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL J&J's RYBREVANT FASPRO™ received FDA approval for once a month dosing schedule for EGFRm NSCLC BMS' NDA for iberdomide + standard treatment has been accepted by the US FDA for R/R MM Deciphera Pharmaceuticals' NDA for tirabrutinib has been accepted by the US FDA for R/R PCNSL ( Ref ) The US FDA has accepted for filing the NDA under the accelerated approval pathway for Deci

12/01/2026 Novita Pharmaceuticals' NP-G2-044 received the FDA orphan drug designation for pancreatic cancer Eureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinomaEureka Therapeutics' ECT204 received the FDA RMAT designation for hepatocellular carcinoma Summit Therapeutics submitted a BLA seeking approval for ivonescimab + chemo in 2L+ EGFRm NSCLC AbbVie acquires ex-China rights to RemeGen's RC148 in a ~$5.6B deal Novita Pharmaceuticals' NP-

08/01/2026 Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC 858 Therapeutics' ETX-19477 received the FDA fast track designation for BRCA-mutated HGSOC Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC ( Ref ) The US FDA granted the breakthrough therapy designation to Revolution Medicines' zoldonrasib (RAS(ON) G12D-selective inhibitor) for the treatment

07/01/2026 Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer   Curadel Pharma's CPI-008 imaging drug received the FDA and EMA orphan drug designation for pancreatic cancer Arbele's ARB1002 received the FDA orphan drug designation for pancreatic cancer ( Ref ) The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. Dr Linda Wu, CDO, Arbele: " Orphan Drug Designation for ARB10

19/11/2025 Roche's Lunsumio SC received conditional approval in EU for R/R FL ( Ref ) The European Commission granted conditional marketing authorisation to Roche's mosunetuzumab (Lunsumio; CD20 x CD3 bispecific antibody) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.  The approval is based on results from the Phase I/II GO29781 trial in which Lunsumio SC had pharmac

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...

24/06/2025 CARsgen Therapeutics submitted a NDA for Satri-cel to China’s NMPA ( Ref ) CARsgen Therapeutics submitted the New Drug...

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