Brexucabtagene autoleucel for the treatment of adults with relapsed or refractory B-cell acute lymphoblastic leukaemia

2 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis

2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...

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Hopes $55k breast cancer drug Keytruda will get PBS listing

3 December 2022 - Women with triple negative breast cancer have been given new hope that immunotherapy drug Keytruda will ...

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EQRx announces acceptance of marketing authorisation application by the European Medicines Agency for aumolertinib in EGFR mutated non-small-cell lung cancer

2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...

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FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation

1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...

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Y-mAbs announces complete response letter for omburtamab biologics license application

1 December 2022 - Y-mAbs Therapeutics today announced that the US FDA has issued a complete response letter for the ...

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Early breast cancer: indication of a minor additional clinical benefit of adjuvant therapy with olaparib

1 December 2022 - Adjuvant treatment with olaparib can prolong life and prevent recurrence in early breast cancer. However, it ...

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Citius Pharmaceuticals announces US FDA acceptance of biologics license application of denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma

1 December 2022 - PDUFA target action date is 28 September 2023. ...

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FDA grants fast track designation to Nuvectis Pharma's NXP800 for the treatment of platinum-resistant, ARID1A mutated ovarian carcinoma

1 December 2022 - Nuvectis Pharma today announced that the US FDA has granted fast track designation to NXP800 for the ...

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Oncolytics Biotech receives FDA fast track designation for the treatment of advanced/metastatic pancreatic cancer

1 December 2022 - FDA fast rack designation granted after presentation at the SITC 37th Annual Meeting demonstrating 69% objective ...

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Cemiplimab for the first-line treatment of patients wth advanced or metastatic PD-L1 positive non-small-cell lung cancer

1 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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Ripretinib for the treatment of patients with an advanced gastro-intestinal stromal tumour after three or more therapies

30 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Roche withdraws Tecentriq from US bladder cancer indication

29 November 2022 - Roche has voluntarily withdrawn the US indication of Tecentriq for treating a form of bladder cancer ...

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Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy

29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...

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Aravive announces fast track designation of batiraxcept for treatment of clear cell renal cell carcinoma

29 November 2022 - FDA decision based on new Phase 1b data. ...

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