FDA approves vimseltinib for symptomatic tenosynovial giant cell tumour

14 February 2025 - Today, the FDA approved vimseltinib (Romvimza, Deciphera Pharmaceuticals), a kinase inhibitor, for adult patients with symptomatic ...

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Keytruda gets expanded coverage for 11 indications at cancer disease panel

13 February 2025 - After nearly two years of stalled discussions, the Keytruda (pembrolizumab) reimbursement expansion debate has finally begun. ...

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Medical imaging agent gozetotide approved for diagnosis of prostate cancer

12 February 2025 - Gozetotide binds to the cancer cells with prostate-specific membrane antigen on their surface, making them visible during ...

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Selpercatinib for the treatment of patients with advanced thyroid cancer with a RET alteration untreated with a targeted cancer medicine

12 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...

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Selpercatinib for the treatment of patients with advanced thyroid cancer with a RET alteration after treatment with a targeted cancer medicine (final guidance)

12 February 2025 - NICE has published final evidence-based recommendations on the use of selpercatinib (Retsevmo) for the treatment of ...

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OnCusp Therapeutics receives FDA fast track designation for CUSP06 for the treatment of platinum-resistant ovarian cancer

12 February 2025 - OnCusp Therapeutics today announced that the US FDA has granted fast track designation to CUSP06, a cadherin-6 ...

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FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

12 February 2025 - On 11 February 2025, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with lenalidomide and a ...

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Health Canada approves Merck's Keytruda (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

11 February 2025 - Approval is based on the Phase 3 KEYNOTE-671 trial. ...

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FDA approves mirdametinib for adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection

11 February 2025 - Today, the FDA approved mirdametinib (Gomekli, SpringWorks Therapeutics), a kinase inhibitor, for adult and paediatric patients ...

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Linvoseltamab BLA accepted for FDA review for the treatment of relapsed/refractory multiple myeloma

11 February 2025 - FDA decision expected by 10 July 2025. ...

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Gilead’s breast cancer treatment Trodelvy passes drug reimbursement panel

7 February 2025 - Gilead's triple negative breast cancer treatment Trodelvy (trastuzumab govitecan) had surmounted a significant hurdle for health ...

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Nivolumab and ipilimumab for the first-line treatment of patients with metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency

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

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Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma

10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an ...

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Gradalis secures FDA regenerative medicine advanced therapy designation for Vigil (gemogenovatucel-T): an investigational personalised immunotherapy for advanced ovarian cancer

5 February 2025 - Recognising clinical evidence from the Phase 2b VITAL Study of Vigil in homologous recombination proficient patients with ...

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Acrivon Therapeutics announces FDA has granted breakthrough device designation for ACR-368 OncoSignature assay for endometrial cancer

5 February 2025 - The ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in ...

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