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

The U.S. Food and Drug Administration (FDA) announced the target action date of its review of the sNDA for VTAMA (tapinarof) cream, 1% has changed.

Organon, which is seeking approval of Vtama as a treatment for atopic dermatitis, said the FDA set a new target action date of March 12 for a decision after requesting the final datasets and ...

Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older Organon (NYSE: OGN), a global healthcare company with a ...

JERSEY CITY, N.J. - Organon (NYSE: OGN), a global healthcare company focused on women's health, announced today that the FDA has extended the review period for the supplemental New Drug Application ...

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

Organon's product portfolio is anchored by several key offerings that have shown promising growth trajectories: 1. VTAMA: This dermatology product has emerged as a significant growth driver for ...

The FDA has not raised any concerns regarding the safety and efficacy of VTAMA nor have they raised any concerns regarding the approvability of this indication. As part of its review process ...

VTAMA: This dermatology product has emerged as a significant growth driver for Organon. Analysts project VTAMA's sales potential to reach $500 million or more, contingent upon successful pediatric ...