10/02/2026 Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer AstraZeneca & Daiichi's Phase 3 TROPION-Lung12 trial in stage I NSCLC has been discontinued Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC ( Ref ) The US FDA granted the fast track designation to Abbisko Therape

09/02/2026 Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC ( Ref ) The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced

Highlights from the CHMP Jan 2026 Meeting are out! Indication Expansions 💊  Johnson & Johnson Innovative Medicine 's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic) 💊  Incyte  and  Takeda 's ponatinib (I

06/02/2026 The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma The FDA approved a label update for Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma ( Ref ) The US FDA approved an update to Gilead's Yescarta® (axicabtagene ciloleucel; anti-CD19 CAR T-cell therapy) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous

05/02/2026 Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma ( Ref ) The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.  Zenocutuzumab is being developed in a subset of

04/02/2026 Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC Oncolytics Biotech's pelareorep-based regimen received the FDA fast track designation for MSS CRC ( Ref ) The US FDA granted the fast track designation to Oncolytics Biotech's pelareorep (oncolytic virus) in combination with bevacizumab (Avastin®) and FOLFIRI for the treatment of patients with KRAS-mutant, MSS metastatic colorectal cancer in the second-line setting. Th