Organon (NYSE:OGN) projected a roughly 75 basis-point headwind to the company’s 2025 EBITDA margin on Tuesday after the FDA ...
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, 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 ...
The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to ...
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 ...
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).
VTAMA ® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque ...
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 ...
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 ...
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.