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...

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC ( Ref ) Nuvalent, Inc has completed its NDA...

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

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC ( Ref ) The European Commission granted marketing...

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

04/07/2025 Imfinzi has been approved by the EC as a perioperative immunotherapy for muscle-invasive bladder cancer ( Ref ) AstraZeneca’s...

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab...

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

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 CHMP May 2025 Meeting are out! ⭐ New Medicines 💊  Autolus Therapeutics ' obecabtagene autoleucel (Aucatzyl; CD19...

Highlights from the CHMP Apr 2025 Meeting are out! ⭐ New Medicines 💊  Jazz Pharmaceuticals  and  BeiGene 's zanidatamab (Ziihera; dual...

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

Cervical cancer ranks as the second most common feminine malignant tumor and the second leading cause of death among female cancers...

Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer...

Breast cancer is the most commonly diagnosed cancer worldwide with a steady increase in incidence rate over the past decades. It is...

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma,...