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Food and Drug Administration (FDA)
Biotech
FDA hits Kezar's zetomipzomib with 2nd clinical hold in 2 months
The FDA has placed a partial hold on the PORTOLA trial evaluating the selective immunoproteasome inhibitor in 24 patients with autoimmune hepatitis.
James Waldron
Nov 13, 2024 5:22am
AstraZeneca, Daiichi pull lung cancer BLA for Enhertu follow-up
Nov 12, 2024 5:27am
FDA places Rapport's nerve damage trial on hold
Nov 7, 2024 8:50am
Lykos accepts FDA view that MDMA med needs new trial for approval
Oct 21, 2024 8:31am
FDA puts Novavax's phase 3 plan on hold for pair of vaccines
Oct 16, 2024 9:10am
PTC bounces back with positive data on FA prospect vatiquinone
Oct 8, 2024 9:34am