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Latest From CytoDyn, Inc.
Keeping Track: Spectrum Submits Poziotinib; US FDA Approves Daré’s Xaciato, Expands Heron Zynrelef Label
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.
Market Snapshot: Gilead’s Biktarvy and ViiV’s two-drug regimens are expected to dominate the HIV market over the next few years as market exclusivity losses loom, but drugs with new mechanisms of action, and longer-acting products, might influence market dynamics.
US FDA declines to review the CCR5 antagonist for use in highly treatment-experienced HIV patients. Safety data from an ongoing study should be sufficient to address the agency’s concerns about the higher 700mg dose, CytoDyn management says, but FDA also has questions about the production of the self-injectable syringes.
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