Bristol Myers Squibb receives positive CHMP opinion for CAR T cell therapy Breyanzi (lisocabtagene maraleucel) for relapsed or refractory DLBCL, PMBCL and FL3B

28 January 2022 - Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients ...

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Bristol Myers Squibb receives approval for Abecma (idecabtagene vicleucel), the first CAR T therapy approved for the treatment of multiple myeloma in Japan

20 January 2022 - Bristol-Myers Squibb today announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers

18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...

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$421,000 cancer drug Kymriah becomes eligible for reimbursement

14 January 2022 - Novartis’ breakthrough cancer treatment Kymriah (ingredient: tisagenlecleucel), which costs over 500 million won (US$421,000), has become ...

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CBMG receives FDA regenerative medicine advanced therapy and fast track designations for bi-Specific anti-CD19/CD20 CAR-T cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

12 January 2022 - Cellular Biomedicine Group today announced that the FDA granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting ...

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CARsgen announces CT041 CAR T-cell product candidate granted RMAT designation by the FDA

10 January 2022 - CARsgen Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CT041 for ...

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Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-001 in development for the treatment of AML

27 December 2021 - Celularity today announced the U.S. FDA has granted fast track designation for its non-genetically modified cryopreserved human ...

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Lion TCR receives FDA fast track designation for its HBV specific TCR T cell therapy for hepatocellular carcinoma

23 December 2021 - Lion TCR today announced that it has received fast track designation from U.S. FDA for LioCyx-M004, autologous ...

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EU regulation passed: G-BA works on European HTA assessment

14 December 2021 -  Today the EU Parliament passed the EU-HTA regulation for a joint health technology assessment, which includes, ...

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EMA validates Atara Biotherapeutics' marketing authorisation application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease

30 November 2021 - First ever off the shelf allogeneic T-cell therapy to be reviewed by any regulatory agency in the ...

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U.S. Food and Drug Administration approves Longeveron’s Lomecel-B for rare paediatric disease designation to treat life-threatening infant heart condition

18 November 2021 - Phase 2 clinical trial underway for hypoplastic left heart syndrome, which affects approximately 1,000 babies per ...

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MSAC publishes agenda for upcoming meeting

24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...

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CARsgen announces CAR T-cell product candidate CT041 granted PRIME eligibility by the EMA

15 November 2021 - CARsgen Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) eligibility to CT041 for the ...

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Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel

1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...

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Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma

28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...

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