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This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
Most of the recent conversations about the Food and Drug Administration have centered around the rejection of drugs for rare diseases that might have been approved had regulatory flexibility been applied.
This week, the FDA flexed its regulatory authority to approve the first medicine to treat focal segmental glomerulosclerosis, or FSGS, a rare disease in which scar tissue builds up in the filtering units of the kidneys, eventually leading to organ dysfunction and failure.



