18/03/2026 Idience's venadaparib received the FDA fast track designation for gastric cancer Idience's venadaparib received the FDA fast track designation for gastric cancer ( Ref ) The US FDA granted the fast track designation to Idience's venadaparib (PARP inhibitor) for the treatment of gastric cancer. Lee Won-sik, CEO, Idience: “ This Fast Track designation is highly meaningful in that the FDA has recognized Venadaparib’s clinical potential and its ability to help address

16/03/2026 AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers ( Ref ) The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resecta

09/03/2026 Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC BMS announced positive Ph3 data of oral mezigdomide regimen in R/R Multiple Myeloma AstraZeneca and Daiichi Sankyo’s Enhertu received priority review status for HER2-positive early breast cancer Roche announced failure of the Phase 3 persevERA Breast Cancer trial   Johnson & Johnson's AKEEGA regimen received EC approval for the treatment of BRCA1/2-mutated mHSPC ( Ref

20/02/2026 The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL The combination of venetoclax and acalabrutinib has been approved by the US FDA for CLL ( Ref ) The US FDA has approved a sNDA for Abbvie & Genentech's venetoclax (BCL-2 inhibitor) + AstraZeneca's acalabrutinib (BTK inhibitor) for the treatment of previously untreated adult patients with CLL The approval is supported by data from the Phase 3 AMPLIFY trial Dr. Brian Koffman, co-f

28/01/2026 Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma ( Ref ) Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib (FGFR2 inhibitor) as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement. Dong-Gun Kim, the company’s chief executive of

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

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