Myelodysplastic Syndrome with 5q Deletion
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FDA approval · 2025-03-03FDA Approved: LENALIDOMIDE — Original Application (BIOCON PHARMA INC.,)
FDA approved Biocon Pharma Inc.'s lenalidomide as an original ANDA, enabling a generic version of the cancer drug. Indications include multi…
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FDA approval · 2024-09-11FDA Approved: LENALIDOMIDE — Original Application (Novugen Pharma (USA) LLC)
FDA approved the original application for lenalidomide from Novugen Pharma (USA) LLC, enabling a generic version of the cancer drug lenalido…
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FDA approval · 2023-10-05FDA Approved: LENALIDOMIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for lenalidomide submitted by Zydus Pharmaceuticals USA Inc. under ANDA210154, updating the lena…
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FDA approval · 2023-03-24FDA Approved: LENALIDOMIDE — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for lenalidomide (ANDA211022), authorizing the marketing of a generic lenalidomide prod…
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FDA approval · 2023-03-24FDA Approved: LENALIDOMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for lenalidomide submitted by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2023-03-06FDA Approved: LENALIDOMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' generic lenalidomide (LENALIDOMIDE) under ANDA211846.
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FDA approval · 2023-03-06FDA Approved: LENALIDOMIDE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Lenalidomide from Mylan Pharmaceuticals as an original application (ANDA), marking the approval of a generic lenalidomide.
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FDA approval · 2023-03-06FDA Approved: LENALIDOMIDE — Original Application (Aurobindo Pharma Limited)
FDA approved Lenalidomide as a generic product under an original application from Aurobindo Pharma Limited.
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FDA approval · 2023-03-06FDA Approved: LENALIDOMIDE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved a generic lenalidomide product for Teva under ANDA201452, expanding access to lenalidomide formulations.
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FDA approval · 2023-02-08FDA Approved: LENALIDOMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approves Sun Pharmaceutical Industries' Lenalidomide Original Application, granting a generic lenalidomide product for multiple myeloma …
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FDA approval · 2022-09-06FDA Approved: LENALIDOMIDE — Original Application (EXELAN PHARMACEUTICALS INC.)
The FDA approved Exelan Pharmaceuticals Inc.'s original application for lenalidomide, granting approval of a generic version of the cancer d…
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FDA approval · 2022-08-31FDA Approved: LENALIDOMIDE — Original Application (Alvogen, Inc.)
FDA approved the original application for Lenalidomide from Alvogen, Inc., enabling a generic version of lenalidomide to enter the market.
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FDA approval · 2022-08-30FDA Approved: LENALIDOMIDE — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved lenalidomide as an original application for Mylan Pharmaceuticals Inc., establishing a generic version of lenalidomide.
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FDA approval · 2021-08-31FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation. The action expands or updates the …
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FDA approval · 2011-12-21FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)
The FDA approves a supplemental application for Revlimid (lenalidomide) submitted by Celgene Corporation, updating regulatory status for the…
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FDA approval · 2010-10-12FDA Approved: REVLIMID — Supplemental Application (Celgene Corporation)
FDA approved a supplemental application for REVLIMID (lenalidomide) submitted by Celgene Corporation.