BioSpace News Archive

FDA

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need

July 31, 2020
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16 min read
RegulatoryMorphoSys AG: Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

MorphoSys AG announces that the U.S. Food and Drug Administration has approved Monjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

July 31, 2020
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4 min read
FDA

FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need

July 31, 2020
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16 min read
Policy

FDA In Brief: FDA Advises Consumers to Avoid Red Onions from California Supplier, Investigation Continues to Find Source

The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response:

July 31, 2020
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2 min read
FDA

FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

The U.S. Food and Drug Administration approved Epidiolex [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex in patients one year of age and older.

July 31, 2020
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4 min read
FDA

Tuberous Sclerosis Alliance Lauds FDA Approval of Epidiolex® to Treat Seizures in People with Tuberous Sclerosis Complex

, the Tuberous Sclerosis Alliance lauds the U.S. Food and Drug Administration’s approval of Epidiolex® oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex.

July 31, 2020
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2 min read
FDA

Xencor Earns Milestone Payment from MorphoSys for FDA Approval of Monjuvi® (tafasitamab-cxix) in the United States

Monjuvi is a new treatment in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL)

July 31, 2020
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5 min read