Latest news with #U.S.FDAOncologicDrugsAdvisoryCommittee
Business Insider
6 days ago
- Business
- Business Insider
GSK provides update on US FDA advisory committee review of Blenrep
GSK (GSK) notes that the U.S. FDA Oncologic Drugs Advisory Committee voted against the overall benefit/risk profile at the proposed dosage of Blenrep combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the July 23 PDUFA date. GSK remains confident in the benefit/risk profile of Blenrep and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Business Insider
21-05-2025
- Business
- Business Insider
Johnson & Johnson: FDA panel votes 6-2 in favor of Darzalex Faspro
Johnson & Johnson the U.S. FDA Oncologic Drugs Advisory Committee voted (6-2) in favor of the benefit-risk profile of single-agent Darzalex Faspro for the treatment of adult patients with high-risk smoldering multiple myeloma. An application for the approval of Darzalex Faspro for adult patients with HR-SMM was submitted to the FDA in November 2024. Confident Investing Starts Here:
