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.