Organon (NYSE:OGN) projected a roughly 75 basis-point headwind to the company’s 2025 EBITDA margin on Tuesday after the FDA ...

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 ...

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 ...

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

Q3 2024 Earnings Call Transcript October 31, 2024 8:30 AM ETCompany ParticipantsJennifer Halchak - VP, IRKevin Ali - ...

Dermavant Sciences has shared positive long-term results for its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years old with atopic dermatitis (AD).

Please see our prior announcement for a summary of the transaction terms. VTAMA ® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug ...

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 ...

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 ...

The Merck (MRK) spinoff said that the regulator had assigned March 12, 2025, as the new target action date for the company’s supplemental New Drug Application for VTAMA after adding a standard ...

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.