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2. Daratumumab - Wikipedia

   en.wikipedia.org/wiki/Daratumumab

   Daratumumab was given priority review status by the US Food and Drug Administration (FDA) for multiple myeloma as a combination therapy (second line). [ 24 ] Daratumumab phase III trials for multiple myeloma show great promise in combination therapy with lenalidomide and dexamethasone , [ 32 ] as well as with bortezomib and dexamethasone .

3. Daratumumab/hyaluronidase - Wikipedia

   en.wikipedia.org/wiki/Daratumumab/hyaluronidase

   It was approved for use in the United States in May 2020. [2] [7] [8]Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV). [2]

4. Genmab’s Darzalex Gets FDA Approval For Blood ... - AOL

   www.aol.com/news/genmab-darzalex-gets-fda...

   Genmab A/S announced on Jan. 15 that its drug, Darzalex Faspro has been approved by the US Food and Drug Administration (FDA) for the treatment of light-chain (AL) amyloidosis in adult patients ...

5. Amgen (AMGN) Kyprolis Gets FDA Nod for Use With Darzalex Faspro

   www.aol.com/news/amgen-amgn-kyprolis-gets-fda...

   Amgen (AMGN) gets FDA nod for the label expansion of Kyprolis in combination with Darzalex Faspro and dexamethasone for treating patients with multiple myeloma at first or subsequent relapse.

6. Approved drug - Wikipedia

   en.wikipedia.org/wiki/Approved_drug

   A fee is required to make such FDA submission. For financial year 2020, this fee was: for an application requiring clinical data ($2,942,965) and for an application not requiring clinical data ($1,471,483). [4] A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling.

7. FDA approves opioid-free pain medication with 'no sign of ...

   www.aol.com/fda-approves-opioid-free-pain...

   A new opioid-free pain medication was approved by the U.S. Food and Drug Administration (FDA) on Thursday, marking a non-addictive alternative for patients. Journavx (suzetrigine), made by Vertex ...