Blog
RSS FeedPosted by Michael Wonder on 04 Dec 2022
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 ...
Posted by Michael Wonder on 03 Dec 2022
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 ...
Posted by Michael Wonder on 03 Dec 2022
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 ...
Posted by Michael Wonder on 03 Dec 2022
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 ...
Posted by Michael Wonder on 02 Dec 2022
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 ...
Posted by Michael Wonder on 02 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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. ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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. ...
Posted by Michael Wonder on 29 Nov 2022
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. ...