Food and Drug Administration (FDA)

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Biotech

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

When the FDA turned down Lykos’ application, the regulator explained that it could not approve the treatment based on the data submitted to date.
James Waldron 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
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FDA places Kezar lupus trial in hold following 4 patient deaths

Oct 7, 2024 5:50am
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Vanda receives FDA rejection, issues fiery response

Sep 19, 2024 8:02am
FDA

FDA scraps adcomm for Applied's rare disease drug

Sep 18, 2024 8:00am