26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
17 May 2023 - NICE is unable to make a recommendation on the use of ciltacabtagene autoleucel (Carvykti) for the treatment ...
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
4 May 2023 - HAV granted second RMAT designation by the FDA. ...
3 May 2023 - Approval of Breyanzi based on the pivotal Phase 3 TRANSFORM trial, in which Breyanzi significantly improved ...
27 April 2023 - NICE recommends two CAR-T therapies, both given as one-off infusions, to treat aggressive forms of blood ...
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
17 April 2023 - Today, the US FDA approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken ...
12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...
4 April 2023 - CaMMouflage Phase 1 trial for CB-011 enrolling patients with relapsed or refractory multiple myeloma at dose level ...
31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...
24 March 2023 - First TIL therapy BLA submission to US FDA. ...
23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...