- FDA approves daratumumab and hyaluronidase|fihj with bortezomib ...🔍
- Daratumumab 🔍
- Daratumumab for Treatment of Multiple Myeloma After One Prior ...🔍
- FDA approves daratumumab for transplant|eligible multiple myeloma🔍
- FDA approves daratumumab and hyaluronidase|fihj with ...🔍
- FDA Approves Subcutaneous Daratumumab Plus VRd in Multiple ...🔍
- DARZALEX FASPRO® 🔍
- FDA Approves New Use for Daratumumab in Multiple Myeloma🔍
Daratumumab Approved by FDA for Pretreated Multiple Myeloma
FDA approves daratumumab and hyaluronidase-fihj with bortezomib ...
On July 30, 2024, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Research ...
Daratumumab was previously granted accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received ...
Daratumumab for Treatment of Multiple Myeloma After One Prior ...
Multiple myeloma is mostly an incurable disease. The U.S. Food and Drug Administration (FDA) granted daratumumab accelerated approval in November 2015 as ...
FDA approves daratumumab for transplant-eligible multiple myeloma
On September 26, 2019, the Food and Drug Administration approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination ...
FDA approves daratumumab and hyaluronidase-fihj with ...
FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma ... On July 9, 2021, the Food and Drug ...
FDA Approves Subcutaneous Daratumumab Plus VRd in Multiple ...
The FDA approved Darzalex Faspro plus VRd for induction and consolidation in select patients with newly diagnosed multiple myeloma.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with ...
Darzalex (daratumumab) FDA Approval History - Drugs.com
Darzalex (daratumumab) is a human anti-CD38 monoclonal antibody indicated for the treatment of patients with multiple myeloma. Darzalex is ...
FDA Approves New Use for Daratumumab in Multiple Myeloma - NCI
It's thought to work both by killing tumor cells directly and by stimulating an immune response against cancer cells. The drug's new approval is ...
FDA Approves Daratumumab Plus VRd in Newly Diagnosed ...
The FDA has approved subcutaneous daratumumab plus VRd for induction and consolidation in patients with newly diagnosed multiple myeloma who are ...
Daratumumab Plus Standard Therapy for Multiple Myeloma - NCI
Daratumumab is already FDA approved to be used with other drug combinations for newly diagnosed multiple myeloma. One such combination includes ...
Johnson & Johnson submits applications in the U.S. and EU seeking ...
If approved, DARZALEX FASPRO® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of ...
FDA approves daratumumab and hyaluronidase-fihj for multiple ...
On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO, Janssen Biotech, Inc.) for adult patients ...
sBLA Submitted to FDA for Subcutaneous Daratumumab Plus VRd ...
A sBLA seeking the approval of D-VRd for transplant-eligible patients with newly diagnosed multiple myeloma was submitted to the FDA.
FDA Approves Daratumumab and Hyaluronidase-fihj With ...
On July 9, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with ...
FDA Approves Daratumumab for Patients with Transplant-Ineligible ...
On June 27, 2019, the U.S. Food and Drug Administration (FDA) approved daratumumab, in combination with lenalidomide and dexamethasone, ...
FDA approves carfilzomib and daratumumab with dexamethasone ...
FDA approves carfilzomib and daratumumab with dexamethasone for multiple ... On August 20, 2020, the Food and Drug Administration approved carfilzomib ...
FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for ...
FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple ... On November 30, 2021, the Food and Drug Administration approved daratumumab + ...
Daratumumab Approved by FDA for Pretreated Multiple Myeloma
The FDA has given accelerated approval to the CD38-targeted monoclonal antibody daratumumab as a monotherapy for patients with multiple ...
FDA Approves Daratumumab for Pretreated Multiple Myeloma
Acting 4 months ahead of schedule, the FDA has granted an accelerated approval to daratumumab (Darzalex) as a monotherapy for patients with multiple myeloma ...