The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

Syndax Pharmaceuticals advances Revumenib for relapsed AML with FDA decision pending. See why SNDX stock is a key player in ...

Syndax Pharmaceuticals (SNDX) stock dropped ~23% after the company posted Phase 2 trial data for its AML candidate, revumenib ...

The FDA approved zolbetuximab (Vyloy) on October 18, 2024, as a first-line treatment for locally advanced unresectable or ...

The FDA has extended the review period for the sNDA for tapinarof cream, 1% in the treatment of atopic dermatitis.

The new PDUFA target date is March 12, 2025. The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the ...

Organon (OGN) announced that the FDA extended by three months the target action date of its review of the supplemental New Drug Application, or ...

has informed the Company that it is continuing its review of the supplemental New Drug Application (sNDA) for full approval of OCALIVA ® (obeticholic acid, OCA) for the treatment of indicated ...

has approved Avadel Pharmaceuticals’ supplemental new drug application for extended-release sodium oxybate (Lumryz) for treatment of cataplexy or excessive daytime sleepiness in children 7 years ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz. The drug is now approved in the United States ...

Asia-Pacific – The Asia-Pacific region is projected to experience the highest growth in the galactoarabinan market, primarily ...