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

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 ...

Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking ...

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 ...

Organon (OGN) stock on watch as FDA delays a potential label expansion for its VTAMA cream, impacting 2025 EBITDA margin and ...

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 ...

Topline results are expected in Q4 2025 and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data. Grünenthal announced ...

In light of new data, JAZZ said it would submit a supplemental New Drug Application to the FDA seeking label expansion for the drug as a first-line maintenance treatment for ES-SCLC. A separate ...

Incyte (Nasdaq:INCY) today reports 2024 third quarter financial results, and provides a status update on the Company’s clinical development portfolio. "In the third quarter of 2024, we delivered ...