Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Merck, Moderna, Sumitomo, Urogen, Xediton.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astria, Beam, Bioarctic, Biorestorative, Celldex, Enliven, Incyte, Johnson& Johnson, Kancera, Keymed, Silence.
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