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Latest From Intercept Pharmaceuticals, Inc.
Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration
As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).
No More NASHing Of Teeth: Madrigal’s Resmetirom Approval Ends Years Of Industry Frustration
US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.
Gilead Offers Up $4.3bn For CymaBay And Phase III PBC Candidate
Adding to its liver disease portfolio, Gilead agreed to pay a 27% premium for CymaBay and seladelpar, which has a 14 August FDA action date to compete in second-line primary biliary cholangitis.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
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