25 February 2021 - NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more ...
24 February 2021 - Treatment with autologous anti-CD19-transduced CD3+ cells (brexucabtagene autoleucel) is recommended for use within the Cancer Drugs Fund ...
22 February 2021 - Innovent Biologics today jointly announce that the Center for Drug Evaluation of China's National Medical Products Administration ...
19 February 2021 - Submission of a biologic license application to FDA planned for Q3 2021. ...
12 February 2021 - bluebird bio’s beta thalassaemia gene therapy betibeglogene autotemcel (beti-cel) has not been recommended by the UK’s ...
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with ...
1 February 2021 - Janssen announced today that the CHMP of the EMA will perform an accelerated assessment of the ...
22 January 2021 - Approval based on phase 2 study conducted in Japan and previous pivotal trial data. ...
11 January 2021 - FDA determines ReNu preliminary clinical evidence indicates potential to address unmet medical needs for the management of ...
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
17 December 2020 - Independent appraisal committee determines current evidence is adequate to demonstrate that nadofaragene firadenovec and oportuzumab monatox ...
16 December 2020 - 93% of patients in ZUMA-2 pivotal trial responded to single infusion of Tecartus. ...