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Express precise treatment of non-small cell lung cancer, FDA granted EGFR inhibitor breakthrough therapy designation
Time of Update: 2022-01-08
▎Editor of WuXi AppTec's content team On January 4, 2022, Cullinan Oncology announced that the US FDA has granted the epidermal growth factor receptor (EGFR) inhibitor CLN-081 breakthrough therapy designation for the treatment of previous systemic drugs.
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The review date of Legendary Bio's BCMA CAR-T cell therapy was postponed by the U.S. FDA for 3 months
Time of Update: 2021-12-09
In a brief statement, Nanjing Legend and Yang Sen stated that the postponement is to "enough time to review information on an updated analytical method following a recent FDA information request .
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Genxi Biologics' BCMA/CD19 dual-target CAR-T cell therapy GC012F for the treatment of multiple
Time of Update: 2021-12-06
S. Food and Drug Administration (FDA) has granted it the orphan of the BCMA/CD19 dual-target CAR-T cell therapy developed based on the FasTCAR technology platform Drug qualification (ODD) for the treatment of multiple myeloma .
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FDA accepts Novartis CAR-T cell therapy Kymriah supplementary biologics license application
Time of Update: 2021-11-15
CompilationTom LeeRecently, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have respectively accepted Novartis’ Kymriah (tisagenlecleucel) as a treatment for relapsed or refractory (r/r) follicular lymphoma (FL) adults The patient’s application for review .
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Express treatment of acute myeloid leukemia, CRISPR-edited stem cell therapy obtained FDA fast track qualification
Time of Update: 2021-10-02
▎ WuXi AppTec content team editor September 9, 2021, Vor Biopharma announced that the US FDA has granted its engineered hematopoietic stem cell (eHSC) candidate drug VOR33 fast track qualification for the treatment of acute myeloid leukemia (AML) .
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CRISPR-edited stem cell therapy for the treatment of acute myeloid leukemia obtains FDA fast-track qualification
Time of Update: 2021-09-19
S. FDA has granted its engineered hematopoietic stem cell (eHSC) candidate drug VOR33 fast track qualification for the treatment of acute myeloid leukemia (AML) .
Therefore, the hematopoietic stem cells infused back into the patient will produce healthy new cells that do not express CD33 protein .
com/news-releases/news-release-details/vor33-granted-us-fda-fast- track-designation-aml
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Due to safety issues, the FDA suspends a clinical trial of cell therapy for hemophilia, Sigilon's stock price plummets
Time of Update: 2021-08-10
. Recently, FDA suspended the encapsulated cell therapy clinical trials Sigilon Therapeutics company's treatment of hemophilia A type .
Sigilon Therapeutics developed the hemophilia type A cell therapy numbered SIG-001, which aims to restore the patient’s ability to produce coagulation factors.
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Bayer's cell therapy for advanced Parkinson's disease obtains FDA fast-track qualification
Time of Update: 2021-07-31
DA01 is a therapy that BlueRock uses pluripotent stem cells to generate dopaminergic neurons, and is currently being evaluated through a phase I clinical trial .
The main purpose of this phase I clinical study is to evaluate the safety and tolerability of DA01 cell transplantation during the one-year period after transplantation .
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FDA suspends clinical study of bluebird bio-sickle cell disease gene therapy
Time of Update: 2021-07-25
On February 23, bluebird bio announced that the US FDA has put on hold its LentiGlobin gene therapy clinical trial program for the treatment of sickle cell disease (SCD) .
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The FDA is disappointed with the slow progress in the application of stem cell therapy
Time of Update: 2021-06-22
[FDA announced a comprehensive regenerative medicine policy framework 2017/11/18] Bryan said that for the manufacturers of these products, the period of law enforcement discretion is now over .
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Express | Treatment of specific non-small cell lung cancer, FDA accelerates approval of Janssen bispecific antibody precision therapy
Time of Update: 2021-06-02
S. FDA announced that it has approved the listing of the EGFR/MET bispecific antibody therapy Rybrevant (amivantamab-vmjw) developed by Janssen, a subsidiary of Johnson & Johnson, for the treatment of insertion mutations carrying EGFR exon 20 Of patients with non-small cell lung cancer (NSCLC).
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BCMA CAR-T cell therapy! Johnson & Johnson/Nanjing Legend cilta-cel has been reviewed by the US FDA for priority review: treatment of multiple myeloma!
Time of Update: 2021-06-01
S. Food and Drug Administration (FDA) has accepted the BCMA CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel, formerly known as JNJ-4528/LCAR-B38M, LCAR- B38M CAR-T cell autologous reinfusion preparation ) and granted priority review for the biological product license application (BLA), which is used to treat adult patients with relapsed or refractory multiple myeloma (RRMM).
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Express | For the treatment of non-small cell lung cancer, Takeda's potential "first-in-class" therapy receives FDA priority review
Time of Update: 2021-05-08
S. FDA has granted priority review status for its new drug application for mobocertinib (TAK-788) for the treatment of metastatic EGFR exon 20 insertion Adult patients with non-small cell lung cancer (NSCLC).
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The placenta-derived, allogeneic, natural killer NK cell therapy was awarded the FDA orphan drug
Time of Update: 2021-04-23
Recent popular reports from Yimaike ★ NK cell therapy has been certified by the FDA for fast-track treatment for the treatment of recurrent glioblastoma multiforme in adults Yimai broke the news ★The
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FDA update | Approved targeted BCMA CAR-T cell therapy idecabtagene vicleucel to treat patients with multiple myeloma
Time of Update: 2021-04-14
S. Food and Drug Administration (FDA) approved idecabtagene vicleucel for the treatment of relapsed/refractory multiple cases that have previously received ≥4-line therapies (including immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies) Adult patients with sexual myeloma.