Tag: Janssen Biotech

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Niraparib and abiraterone acetate plus prednisone is approved by FDA for BRCA-mutated metastatic castration-resistant prostate cancer

August 2023: The fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.), along with prednisone, has been approved by the Food and Drug Administration for adult patients with castration-resista..

Talvey-Janssen
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Talquetamab-tgvs has received accelerated approval for relapsed or refractory multiple myeloma

August 2023: Talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) has been given accelerated approval by the Food and Drug Administration for the treatment of adults with relapsed or refractory multiple myeloma who have undergone at ..

Teclistamab-cqyv tecvayli
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Teclistamab-cqyv is approved by FDA for relapsed or refractory multiple myeloma

November 2022: The first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), was given accelerated approval by the Food and Drug Administration for adult pat..

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CARVYKTI (ciltacabtagene autoleucel), BCMA-Directed CAR-T Therapy, receives U.S. FDA approval for the treatment of adult patients with relapsed or refractory multiple myeloma

March 2022: According to Johnson & Johnson, a therapy developed by the company and its China-based partner Legend Biotech Corp to treat a kind of white blood cell cancer has been approved by the US Food and Drug Administrati..

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Ciltacabtagene autoleucel is approved for relapsed or refractory multiple myeloma

March 2022: After four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, the Food and Drug Administration has approved ciltacabtagene au..

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Darzalex faspro, kyprolis, and dexamethasone is approved by FDA for multiple myeloma

March 2022: Daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone have been approved by the Food and Drug Administration for adult patients with relap..

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Daratumumab and hyaluronidase-fihj plus pomalidomide and dexamethasone have been approved by the FDA for the treatment of multiple myeloma

August 2021: Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) have been approved by the Food and Drug Administration in combination with pomalidomide and dexamethasone for adult patients with multiple my..

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