Rare cancer lifeline comes with dual drug discounts

17 October 2025 - Two common immunotherapy drugs will now be subsidised for all advanced or metastatic cancers, providing a ...

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Immunotherapy for patients with advanced cancers

17 October 2025 - More Australians living with advanced cancer could have access to immunotherapy treatment options, thanks to a ...

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NovelWise Pharmaceutical receives FDA fast track designation for NBM-BMX in metastatic uveal melanoma

14 October 2025 - NovelWise Pharmaceutical today announced that the US FDA has granted fast track designation for NBM-BMX, a ...

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Corcept submits marketing authorisation application to EMA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer

14 October 2025 - Corcept Therapeutics has submitted a marketing authorisation application to the EMA for relacorilant to treat patients ...

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Akamis Bio receives FDA fast track designation for NG-350A for the treatment of mismatch repair proficient locally advanced rectal cancer

14 October 2025 - NG-350A is a systemically delivered oncolytic immunotherapy driving intra-tumoral expression of a CD40 agonist monoclonal antibody. ...

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Bicara Therapeutics announces ficerafusp alfa granted breakthrough therapy designation by US FDA for first-line HPV negative metastatic or with unresectable, recurrent head and neck squamous cell carcinoma

13 October 2025 - Bicara Therapeutics today announced that the US FDA has granted breakthrough therapy designation to ficerafusp alfa in ...

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BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by US FDA

13 October 2025 - Breakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with ...

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Adcendo ApS announces FDA fast track designation granted to ADCE-D01 for the treatment of soft tissue sarcoma

9 October 2025 - Adcendo ApS today announced that the US FDA has granted fast track designation to ADCE-D01 for ...

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Werewolf Therapeutics receives fast track designation from the US FDA for WTX-124, an investigational therapy for the treatment of cancer

8 October 2025 - Werewolf Therapeutics today announced that the Company has received fast track designation for the use of WTX-124 ...

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FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

8 October 2025 - Today, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous ...

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Ontario connecting patients to life-saving cancer drugs faster

7 October 2025 - The Ontario Government is leading the world in cancer care by launching the Funding Accelerated for ...

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Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk ...

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Orca Bio announces FDA acceptance and priority review of the biologics license application for Orca-T to treat haematological malignancies

6 October 2025 - FDA assigns PDUFA target action date of 6 April 2026. ...

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Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer

1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...

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FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer

3 October 2025 - Regimen recommended in National Comprehensive Cancer Network Guidelines for small cell lung cancer. ...

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