Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO® / DARZALEX® as subcutaneous monotherapy for high-risk smoldering multiple myeloma
Portfolio Pulse from
Johnson & Johnson has submitted applications to the FDA and EMA for the approval of DARZALEX FASPRO® as a subcutaneous monotherapy for high-risk smoldering multiple myeloma. If approved, it will be the first treatment option for this condition, potentially preventing the progression to active disease.
November 08, 2024 | 12:15 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Johnson & Johnson has applied for FDA and EMA approval for DARZALEX FASPRO® as a treatment for high-risk smoldering multiple myeloma. Approval could make it the first treatment option for this condition.
The submission of regulatory applications for a new indication of DARZALEX FASPRO® could lead to its approval as the first treatment for high-risk smoldering multiple myeloma. This would enhance JNJ's product portfolio and potentially increase revenues, positively impacting the stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 90