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 ...

Organon said that as a result of the delay, it now expects Vtama to contribute about $125 million in revenue next year, with the Dermavant deal reducing its 2025 adjusted earnings before interest ...

Organon , a global healthcare company with a mission to improve the health of women throughout their lives, today announced that the U.S. Food and Drug Administration (FDA) extended by three months ...

statements about management’s expectations regarding Organon’s recent acquisition of Dermavant Sciences Ltd. (“Dermavant”) and potential regulatory approval from the FDA for the use of ...

Organon is paying $175 million upfront to buy Roivant's dermatology unit Dermavant and its topical psoriasis therapy Vtama, which is also under review by the FDA for atopic dermatitis. Discover ...

Organon is paying $175 million upfront to buy Roivant's dermatology unit Dermavant and its topical psoriasis therapy Vtama, which is also under review by the FDA for atopic dermatitis. The AI ...

The Prescription Drug User Fee Act (PDUFA) date for Dermavant's (now part of Organon) tapinarof cream, 1% (VTAMA) to treat atopic dermatitis in adults and children aged 2 years and up, has been ...

Armstrong has been a consultant, advisory board member, and/or speaker for Abbvie, ASLAN, Almirall, Amgen, Arcutis, Beiersdorf, BMS, Boehringer Ingelheim, Dermavant ...

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

Organon & Co. (NYSE:OGN) shareholders are probably feeling a little disappointed, since its shares fell 3.1% to US$16.92 in the week after its latest quarterly results. Results were roughly in ...