Food and Drug Administration (FDA)

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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

AstraZeneca, Daiichi pull lung cancer BLA for Enhertu follow-up

Nov 12, 2024 5:27am
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FDA places Rapport's nerve damage trial on hold

Nov 7, 2024 8:50am
FDA stop sign

Lykos accepts FDA view that MDMA med needs new trial for approval

Oct 21, 2024 8:31am
Novavax

FDA puts Novavax's phase 3 plan on hold for pair of vaccines

Oct 16, 2024 9:10am
Roadtrip Sunrise

PTC bounces back with positive data on FA prospect vatiquinone

Oct 8, 2024 9:34am