Obecabtagene autoleucel for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukaemia

13 June 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML

16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...

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AbbVie’s Epkinly, Eisai’s Lenvima pass reimbursement review; Janssen’s Tecvayli fails

11 June 2025 - AbbVie Korea's Epkinly (epcoritamab), a treatment for adults with relapsed or refractory diffuse large B-cell lymphoma ...

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FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma

12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...

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FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer

12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...

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US FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications

11 June 2025 - New formulation provides patients with a simplified dosing experience—reducing pill burden and enhancing ease of administration—while ...

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Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front

12 June 2025 - It took two years, 100,000 signatures, and a wave of public pressure from patients and doctors. ...

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Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases

11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...

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Cantargia’s nadunolimab antibody awarded US FDA fast track designation

11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...

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FDA approves taletrectinib for ROS1 positive non-small cell lung cancer

11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...

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Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted US FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer

10 June 2025 - Target action (PDUFA) date set for 7 October 2025. ...

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Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer

6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner ...

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Fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia in the first-line setting

6 June 2025 - AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for ...

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Chimeric Therapeutics CDH17 receives FDA fast track

4 June 2025 - Chimeric Therapeutics is pleased to announce that the US FDA has granted CHM CDH17 fast track ...

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Cellectar granted US FDA breakthrough therapy designation for iopofosine I 131 in Waldenstrom macroglobulinemia

4 June 2025 - Designation supported by CLOVER WaM Phase 2 study data which reported an 83.6% overall response rate. ...

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