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FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj ...

Published

13 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at fda.gov

Verified

Fusion42 · 14 August 2026 · Fusion42 review

The FDA granted accelerated approval for iberdomide combined with daratumumab, hyaluronidase-fihj, and dexamethasone to treat adults with relapsed or refractory multiple myeloma who have had prior therapies. The approval is based on enhanced efficacy in minimal residual disease-negative complete response shown in a Phase 3 trial.

This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.

◆ The Wire takeaway

You can access a new FDA-approved drug combo for multiple myeloma that shortens developmental timelines after one prior therapy. This approval opens a faster path to market for cancer drug founders using similar trial designs and accelerated pathways.

Coverage

3 sources · 13 Aug 2026

Related on Wire

Topics

Biotechmultiple-myelomafda-approvaloncologydrug-combinationclinical-trial