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Johnson & Johnson (NYSE:JNJ) recently garnered attention when the FDA's Oncologic Drugs Advisory Committee voted favorably on ...
Positive feedback was based on Phase III AQUILA trial results, which showed a significant clinical benefit with Darzalex Faspro in patients with high-risk smoldering multiple myeloma.
The FDA'S ODAC has casted their votes on the use of certain treatments in both the relapsed/refractory DLBCL and myeloma ...
The FDA is likely to approve the first treatment for smoldering multiple myeloma but pass on a new option relapsed/refractory DLBCL, after votes by its Oncologic Drugs Advisory Committee.
Johnson & Johnson has won the support of an FDA expert panel in its bid to make Darzalex the first treatment for an early ...
The pharmaceutical company said Tuesday the FDA's Oncologic Drugs Advisory Committee voted 6-2 in favor of Darzalex Faspro, or daratumumab and hyaluronidase-fihj, to treat adult patients with ...
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For J&J, there was a positive outcome as the Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of approval ...
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Medpage Today on MSNDaratumumab Passes Key Hurdle to First Approved Treatment for Smoldering MyelomaAs reported late last year, the AQUILA trial showed that treatment with daratumumab reduced the risk of progression to ...
The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson ...
In a 6 to 2 vote, the Oncologic Drug Advisory Committee determined that findings from the phase 3 AQUILA trial do/do not ...
One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving ...
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