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

19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer  Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer ( Ref ) The EMA has validated the type II variation marketing author

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

03/02/2026 Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer The US FDA granted priority review status to Datroway for the treatment of TNBC Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer ( Ref ) The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults wi

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

01/10/2025 The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer ( Ref ) Daiichi Sankyo and...

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

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast...

15/09/2025 Daiichi and Merck's raludotatug deruxtecan received the Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or...

11/09/2025 Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan has been accepted for review in the EU for HER2 +ve solid tumors ( Ref...

27/08/2025 BeOne Medicines' perioperative tislelizumab regimen received approval from the EC for resectable NSCLC ( Ref ) The EC approved...

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC ( Ref ) The US FDA...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...

18/06/2025 The Phase 3 IDeate-Prostate01 trial of ifinatamab deruxtecan has been initiated in pretreated, metastatic CRPC patients ( Ref...

April 4th Week, 2025 Regulatory & Market News 🎯  Akeso Biopharma ’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for...

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive...

Bladder cancer is the most common malignancy of the urinary tract. As of 2022, Bladder Cancer had an incidence of 614,298 patients...

Esophageal cancer is the fourteenth most commonly diagnosed cancer and the eighth leading cause of cancer-related death worldwide. The...

Acute myeloid leukemia (AML) is the most common type of leukemia among the adult population and accounts for about 80% of all cases. Despite development of novel treatment options and targeted therapeutics, the 5-year survival rate in adult population is quite low, indicating towards a huge unmet need in AML treatment space. The current infographic concisely highlights the key treatment options for AML and some of the emerging therapeutic stratagems.