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 ...

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

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

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

Arcutis Biotherapeutics Inc ( (ARQT) ) has released its Q3 earnings. Here is a breakdown of the information Arcutis Biotherapeutics Inc ...

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 ...

UCB submitted a supplemental biologics license application for bimekuzimab (Bimzelyx) to the FDA in April for the drug’s approval in moderate to severe hidradenitis suppurativa (HS).

(Nasdaq: EXEL) today reported financial results for the third quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated ...

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 ...