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 ...

--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the submission of its supplemental New Drug Application (sNDA) to the U.S ...

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 ...

Bayer BAYRY announced the submission of a supplemental new drug application (sNDA) to the FDA for darolutamide. The sNDA is ...

The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis in adults and ...

date for the drug’s supplemental New Drug Application (sNDA) being on 15 October. The treatment is only available to primary ...

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 ...

approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness, called cataplexy, or excessive daytime sleepiness (EDS ...

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 ...