Shares in Gensight Biologics SA dropped by as much as 41% April 7 on news that the Paris-based gene therapy firm failed to complete a second manufacturing campaign within five months, a setback that could delay a commercial launch of its lead product, Lumevoq, by at least a year.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
Hansoh Pharmaceutical Group Co. Ltd. has won a green light for inebilizumab, approved by China’s NMPA for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. The decision marked Hansoh’s first biologic approval.
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