Organon updates outlook as FDA delays VTAMA label expansion
Organon (NYSE:OGN) projected a roughly 75 basis-point headwind to the company’s 2025 EBITDA margin on Tuesday after the FDA ...
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 ...
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 ...
Morningstar5d
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
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 ...
GlobalData on MSN11d
Dermavant acquisition expands Organon’s dermatology portfolio
The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to ...
Monthly Prescribing Reference4d
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 ...
PMLiVE9d
Dermavant reports positive long-term results for Vtama cream in atopic dermatitis
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).
Organon & Co. (OGN) Q3 2024 Earnings Call Transcript
Q3 2024 Earnings Call Transcript October 31, 2024 8:30 AM ETCompany ParticipantsJennifer Halchak - VP, IRKevin Ali - ...
Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%
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 ...
Nasdaq4d
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 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 ...
Yahoo Finance13d
Organon Completes Acquisition of Dermavant, including Innovative Dermatologic Therapy, VTAMA® (tapinarof) Cream, 1%
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 ...
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.