I will also explain why I upgraded OGN stock to buy from hold, despite the additional uncertainty stemming from the Dermavant ...

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 ...

Q2 2024 Earnings Call Transcript November 12, 2024 Operator: Good day and thank you for standing by. Welcome to the Roivant ...

Its drug candidate VTAMA (tapinarof) is a treatment of plaque psoriasis in adult patients and is in its commercial stage. The other drug candidates in their different stages of development are; ...

One critical focus for Roivant Sciences is its pipeline. Its success is heavily reliant on products like VTAMA, currently ...

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 ...

Organon said the Food and Drug Administration extended by three months its review of an application seeking expanded approval of the healthcare company's recently acquired skin-care cream Vtama.

JERSEY CITY, N.J. - Organon (NYSE: OGN), a global healthcare company focused on women's health, announced today that the FDA has extended the review period for the supplemental New Drug Application ...

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 ...

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 ...

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in ...