A potential first-ever FDA-approved treatment for smoldering myeloma received a positive review from an advisory committee, but not without reservations, even from panelists who voted in favor. By a 6 ...
Treating high-risk smoldering multiple myeloma with single-agent daratumumab (Darzalex) delayed progression to active myeloma, according to findings from the phase III AQUILA trial presented at the ...
Darzalex Faspro's FDA application targets high-risk smoldering multiple myeloma, a precursor to active multiple myeloma with no current approved treatments. The phase 3 AQUILA study supports the ...
Attendees of the American Society of Hematology's annual meeting walk across a conference hall in December 2022. This story was originally published on BioPharma Dive. To receive daily news and ...
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. This story was originally published on BioPharma Dive. To receive daily news ...
Please provide your email address to receive an email when new articles are posted on . Daratumumab delayed progression of smoldering multiple myeloma compared with active monitoring. Among those who ...
Minimal residual disease (MRD) refers to the small number of myeloma cells that may remain after treatment and are not detectable using conventional response criteria. In multiple myeloma, MRD ...
Phase 3 AQUILA study showed DARZALEX FASPRO ® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring Landmark approval supports ...
Darzalex Faspro reduced the risk of disease progression to active multiple myeloma or death by 51% compared with active monitoring. The Food and Drug Administration (FDA) has approved Darzalex Faspro ...
Smoldering multiple myeloma is an asymptomatic, precancerous condition with abnormal plasma cells and elevated monoclonal protein levels. Diagnosis involves blood, urine, and bone marrow tests, with ...
Smoldering multiple myeloma is a condition in which abnormal plasma cells accumulate in the bone marrow but do not display symptoms of active multiple myeloma. High-risk SMM, however, carries a ...
SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results