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Latest From X4 Pharmaceuticals
US FDA’s April Outlook: Decisions Pending For Rare Pediatric Diseases, New Antibiotics
User fee goal dates in April include four novel agents with breakthrough therapy designations, including Pfizer’s hemophilia B gene therapy and Immunity Bio’s IL-15 superagonist complex for bladder cancer.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
Keeping Track: Rybrevant Goes RTOR, Two-Part Review For Dasiglucagon, And CRL For Ultomiris
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Finance Watch: Sage Warns Of Job Cuts, Joins Peers Making Cash Last After Setbacks
Public Company Edition: Sage will reveal cost reductions later in the third quarter after the US FDA approved zuranolone for the smaller of two depression indications. Also, Karyopharm revealed a 20% workforce reduction, Harmony accessed up to $185m in debt and Astellas invested $50m in Poseida.
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