OGN Organon

Organon: FDA accepts sNDA for MIUDELLA copper IUD to extend use to 6 years

FDA accepted Sebela’s sNDA for MIUDELLA to extend the approved duration of use from 3 to 6 years. PDUFA action is expected in Q2 2027. If approved, the hormone-free IUD would offer up to six years of contraception.

Organon presents pooled Phase 3 VTAMA data at 2026 SPD Annual Meeting

Organon presented post-hoc pooled Phase 3 ADORING 1 & 2 data at the 2026 Society for Pediatric Dermatology meeting, showing consistent early improvements in vIGA-AD and EASI75 across pediatric age groups and adults with moderate-to-severe atopic dermatitis. The analysis stratified results by age (2–6, 7–11, 12–17, ≥18 years) and confirmed statistically significant superiority versus vehicle as early as week 2 through week 8.

Organon secures FDA approval expanding TOFIDENCE indications to CRS and COVID-19

FDA approved the sBLA for TOFIDENCE (tocilizumab-bavi) expanding its indications to include CAR-T-induced severe or life-threatening CRS in adults and pediatric patients 2 years and older, and hospitalized COVID-19 patients aged 2 years and older receiving systemic corticosteroids and requiring respiratory support. The approval adds two new indications to the previously approved rheumatology indications, broadening the biosimilar's addressable patient population.

Organon to present VTAMA (tapinarof) AD pooled analysis at AAD 2026

Organon will present a post-hoc pooled analysis of ADORING 1 & 2 Phase 3 data at the 2026 AAD Annual Meeting on March 28, 2026. The analysis shows early and consistent skin clearance and itch improvement with VTAMA cream in patients ≥2 years old with moderate-to-severe atopic dermatitis. No new regulatory action or PDUFA date is announced.