Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Atossa, BMS, Innocare, Kymera, Praxis, Sanofi, Serina.
Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.
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