Possible Treatment for Rare Lymphomas Withdrawn from FDA Consideration
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Possible Treatment for Rare Lymphomas Withdrawn from FDA Consideration

According to a story from AJMC, the drug developer Incyte has made the decision to withdraw its New Drug Application (NDA) for its investigational therapy parsaclisib. This therapy was submitted…

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NDA Withdrawn for Parsaclisib for MCL, MZL, Follicular Lymphoma
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NDA Withdrawn for Parsaclisib for MCL, MZL, Follicular Lymphoma

Incyte has withdrawn its New Drug Application (NDA) for parsaclisib, which is an investigational treatment for various types of lymphoma, including relapsed/refractory mantle cell lymphoma (MCL), follicular lymphoma, and marginal…

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FDA Accepts NDA For Parsaclisib for Non-Hodgkin Lymphoma
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FDA Accepts NDA For Parsaclisib for Non-Hodgkin Lymphoma

The FDA will review parsaclisib as a treatment for Non-Hodgkin lymphoma (NHL) after accepting Incyte's New Drug Application (NDA). Specifically, the NDA was submitted for the treatment of relapsed or…

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FDA Grants Orphan Drug Designation to Cellectar’s CLR 131 for the Sixth Time

  The biopharmaceutical company Cellectar Biosciences recently announced that the FDA granted its lead phospholipid drug conjugate, CLR 131, Orphan Drug Designation(ODD) for treatment of lymphoplasmacytic lymphoma. ODD is granted by…

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Bayer’s Aliqopa Receives Breakthrough Therapy Status for Marginal Zone Lymphoma
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Bayer’s Aliqopa Receives Breakthrough Therapy Status for Marginal Zone Lymphoma

According to a publication from Benzinga, the U.S. Food and Drug Administration has granted Breakthrough Therapy status to Bayer's relapsed follicular lymphoma drug Aliqopa (copanlisib) for the treatment of marginal…

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Possible Treatment for Marginal Zone Lymphoma Earns Orphan Drug Designation
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Possible Treatment for Marginal Zone Lymphoma Earns Orphan Drug Designation

According to a story from globenewswire.com, the biopharmaceutical company TG Therapeutics, Inc. recently made an announcement declaring that the US Food and Drug Administration (FDA) had awarded the company Orphan…

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Updates From Celgene in Follicular Lymphoma, Marginal Zone Lymphoma, Beta Thalassemia, and other Rare Diseases

Celgene Corporation has recently announced two exciting updates for the rare disease community! Update #1 The first big announcement from Celgene was that their supplemental New Drug Application (sNDA) for…

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