Iovance Biotherapeutics announces US FDA acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma

26 May 2023 - Priority review granted with PDUFA action date of 25 November 2023. ...

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Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma

25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...

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Ciltacabtagene autoleucel for the treatment of patients with relapsed or refractory multiple myeloma

17 May 2023 - NICE is unable to make a recommendation on the use of ciltacabtagene autoleucel (Carvykti) for the treatment ...

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ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma

15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...

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Humacyte’s human acellular vessel receives FDA’s regenerative medicine advanced therapy designation for urgent arterial repair following vascular trauma

4 May 2023 - HAV granted second RMAT designation by the FDA. ...

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Bristol Myers Squibb receives European Commission approval for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy

3 May 2023 - Approval of Breyanzi based on the pivotal Phase 3 TRANSFORM trial, in which Breyanzi significantly improved ...

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Two new personalised immunotherapy treatments for aggressive forms of blood cancer recommended for the Cancer Drugs Fund

27 April 2023 - NICE recommends two CAR-T therapies, both given as one-off infusions, to treat aggressive forms of blood ...

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Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma

17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...

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FDA approves cell therapy for patients with blood cancers to reduce risk of infection following stem cell transplantation

17 April 2023 - Today, the US FDA approved Omisirge (omidubicel-onlv), a substantially modified allogeneic cord blood-based cell therapy to quicken ...

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Kala Pharmaceuticals receives FDA fast track designation for KPI-012, a human MSC-S therapy for persistent corneal epithelial defect

12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...

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Caribou Biosciences announces FDA granted fast track designation to CB-011, an allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma

4 April 2023 - CaMMouflage Phase 1 trial for CB-011 enrolling patients with relapsed or refractory multiple myeloma at dose level ...

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Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory large B-cell lymphoma after one prior therapy

31 March 2023 - Recommendation for approval based on Phase 3 TRANSFORM study, supporting the potential of Breyanzi in earlier ...

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Iovance Biotherapeutics completes biologics license application submission for lifileucel in advanced melanoma

24 March 2023 - First TIL therapy BLA submission to US FDA. ...

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Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma

23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...

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FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response

7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...

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