US FDA Pandemic Performance: On-Time Decision Rates Improve; COVID Applications, Supplements Drop
Biosimilars continue their erratic behavior, with the low numbers driving big swings.
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The UK has led the way in granting a marketing authorization for the oral coronavirus treatment, which could help cut hospitalizations and deaths by half.
New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.
Pre-IND inquiries are slowing and the FDA says more late-stage development work is coming.