Organon reports FDA extension of target action date of review of Vtama sNDA
Organon (OGN) announced that the FDA extended by three months the target action date of its review of the supplemental New Drug Application, or ...
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FDA Extends Review of Tapinarof Cream for Atopic Dermatitis
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 ...
Organon: FDA Extends Vtama Atopic-Dermatitis Review to March
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
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 updates outlook as FDA delays VTAMA label expansion
Organon (OGN) stock on watch as FDA delays a potential label expansion for its VTAMA cream, impacting 2025 EBITDA margin and ...