Overview
- Makary, in a CNBC interview, backed FDA scientists, denied favoritism, and said three independent teams reached the same view on Replimune’s melanoma drug.
- NOTUS reported two sources who said he is on thin ice with the White House, while a spokesperson called him an invaluable asset for the administration.
- Bloomberg’s reporting described internal strain at the agency, and a top vaccine official, Vinay Prasad, left the FDA last week.
- Flashpoints fueling the backlash include the FDA’s rejection of Replimune’s therapy and an initial refusal, then reversal, to review Moderna’s mRNA flu vaccine.
- Even as criticism builds, the FDA is piloting “real time clinical trials,” which use AI to stream patient data during studies to speed review timelines.