Historic Approval for MASH, CAR-Ts in the Spotlight

The FDA took center stage last week as it approved the first-ever MASH therapy and considered additional approvals for CAR-T therapies, whose safety the agency has been investigating since last year.

Phew, what a week!

One of the most anticipated FDA decisions of the year dropped last week when the regulator ⁠approved Madrigal’s Rezdiffra⁠ as the first therapy for MASH (⁠formerly known as NASH⁠).

Then on Friday, BioSpace kept a close eye on an ⁠advisory committee discussing⁠ J&J’s Carvykti and BMS’s Abecma, two CAR-T therapies seeking label expansions as earlier lines of treatment in multiple myeloma despite the risk of early death.

Also discussed: BIO’s decision from last week to ⁠cut ties with⁠ the China-based biotech WuXi AppTec.


Greg Slabodkin is the News Editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.    

Heather McKenzie is a senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.


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