26 January 2023 - Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease ...
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu ...
3 January 2023 - Janssen today announced the submission of a marketing authorisation application to the EMA seeking approval of ...
3 January 2023 - Application based on statistically significant and clinically meaningful overall survival and progression-free survival results from the Phase ...
21 December 2022 - Sobi and ADC Therapeutics today announced that the European Commission has granted conditional marketing authorisation for the ...
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
19 December 2022 - Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy. ...
19 December 2022 - Positive opinions based on significant survival benefit in HIMALAYA and POSEIDON Phase 3 trials. ...
2 December 2022 - Application includes data from key Phase 3 trials, including the pivotal MOMENTUM trial, which met all ...
2 December 2022 - Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line ...
22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...
17 November 2022 - Brukinsa is the only Bruton’s tyrosine kinase inhibitor to achieve superiority over ibrutinib in relapsed/refractory chronic lymphocytic ...
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...