5 December 2023 - Priority review granted with PDUFA date of 5 April 2024. ...
5 December 2023 - Recent Phase 3 monotherapy first results demonstrated complete response rate of 75.7% at any time. ...
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
4 December 2023 - Breakthrough therapy designation for novel targeted releasing system based on results from on-going Phase 2b SunRISe-1 ...
1 December 2023 - Shanghai Junshi Biosciences announced that the TGA has accepted the new chemical entity application for toripalimab in ...
29 November 2023 - In China, a single dose vial costs US$280 but in the US it will have a wholesale ...
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
29 November 2023 - This is the third fast track designation for BI 764532. ...
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in ...
28 November 2023 - FDA fast track designation for bile duct cancer granted for CF33-hNIS (Vaxinia) MAST clinical program. ...
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
27 November 2023 - Pivotal Phase 3 study of olvi-vec in platinum resistant/refractory ovarian cancer initiated in September 2022. ...
27 November 2023 - Today, the FDA approved nirogacestat (Ogsiveo, SpringWorks Therapeutics) for adult patients with progressing desmoid tumours who ...