7 December 2023 - EnGeneIC has achieved a significant milestone with the granting of FDA fast track designation for its ...
6 December 2023 - First BLA for an engineered T-cell therapy for solid tumours submitted to US FDA. ...
7 December 2023 - Verzenio's label expanded to include the full study population investigated in the Verzenio Phase 3 monarchE trial. ...
6 December 2023 - BMS announced today that the company has received manufacturing and marketing approval of the supplemental new ...
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 - Thousands of cancer patients in Australia will benefit from a major change that would see Keytruda offered ...
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic ...
1 December 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...