22/12/2025 Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma AstraZeneca and Daiichi Sankyo’s trastuzumab deruxtecan received the FDA breakthrough therapy designation for early breast cancer AstraZeneca's ceralasertib + durvalumab failed to meet the OS endpoint in PD(L)-1 failed NSCLC Roche's mosunetuzumab SC received the FDA accelerated approval for follicular lymphoma ( Ref ) The US FDA granted accelerated approval to Roche's Lunsumio VE

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 worldwide. Nearly 99% of cervical cancer cases are linked to HPV infection, making it largely preventable through HPV vaccination. Despite this, there were 604,127 new global cases and 341,831 deaths in 2020. Localized cervical cancer, which accounts for about 43% of all cases, has a five-year relative survival rate of 91.2%. However, locally adv

Gastric cancer has remained one of the leading causes of cancer-related deaths globally. It was reported as the 5th most common cancer and the 4th leading cause of cancer death worldwide in 2020, with an observed trend of increasing incidence rates in younger adults (<50 years). Despite therapeutic progress, the survival rate for gastric cancer patients remains low, highlighting the unmet need for treatments of further potential. In this concise infographic, we highlight the

Breast cancer is the most commonly diagnosed cancer worldwide with a steady increase in incidence rate over the past decades. It is estimated that, if the current trends remain unchanged, the burden of breast cancer is set to grow to over 3 million new cases and 1 million deaths per year by 2040 as a result of population growth and ageing alone. The infographic highlights the current key options in Breast cancer's evolving treatment paradigm with a glimpse of the emerging the

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma, or bile duct cancer, affects approximately 8,000 individuals annually in the United States, while gallbladder cancer is even less common, with an incidence rate of about 2 per 100,000 people. These cancers are frequently diagnosed at advanced stages, leading to poor prognoses. In the US and EU, treatment options remain scarce, although recen