Caribou Biosciences announces the FDA granted regenerative medicine advanced therapy and fast track designations to CB-010, an allogeneic anti-CD19 CAR-T cell therapy

29 November 2022 - CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout. ...

Read more →

Axicabtagene ciloleucel for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after one systemic treatment

23 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

Read more →

Tisagenlecleucel for the treatment of patients with follicular lymphoma after two or more therapies

22 November 2022 - NICE is unable to make a recommendation on the use of tisagenlecleucel for the treatment of adults ...

Read more →

MSAC can't find a place for Carvykti

10 November 2022 - The outcome from Janssen's application requesting the public funding of ciltacabtagene autoleucel for the treatment of ...

Read more →

Aleta Biotherapeutics receives Innovation Passport Designation for biologic CAR T-cell therapy engager ALETA-001

7 November 2022 - ALETA-001 was developed to address the urgent unmet need of patient relapse after CD19 targeted CAR ...

Read more →

FDA finalises umbrella trial guidance for cell and gene therapies

4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or ...

Read more →

Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5 positive relapsed/refractory PTCL

27 October 2022 - MT-101 is the first mRNA engineered CAR monocyte therapy to be dosed in humans. ...

Read more →

CARsgen announces NDA acceptance of BCMA CAR T zevor-cel (CT053) by China NMPA

18 October 2022 - CARsgen Therapeutics announces that the NMPA of China has accepted the new drug application for zevorcabtagene autoleucel ...

Read more →

Kite’s Yescarta first CAR T-cell therapy to receive European marketing authorisation for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma

17 October 2022 - First treatment in 30 years to improve upon standard care for second-line treatment of DLBCL. ...

Read more →

CHMP recommends approval of Atara Biotherapeutics’ Ebvallo (tabelecleucel) for the treatment of Epstein-Barr virus positive post transplant lymphoproliferative disease

14 October 2022 - Ebvallo on track to be the first ever allogeneic T-cell therapy approved. ...

Read more →

EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

29 September 2022 - EMA is launching a pilot to support the translation of basic research developments into medicines that could ...

Read more →

CRISPR Therapeutics announces FDA regenerative medicine advanced therapy designation granted to CTX130 for the treatment of cutaneous T-cell lymphomas

28 September 2022 - CRISPR Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CTX130, ...

Read more →

Kite’s CAR T-cell therapy Yescarta first in Europe to receive positive CHMP opinion for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma

16 September 2022 - Positive opinion based on landmark ZUMA-7 study in which 41% of patients demonstrated event-free survival at ...

Read more →

Recell System insurance coverage begins in Japan for treatment of acute burns

1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...

Read more →

US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants

31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...

Read more →