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Incyte
NEWS

Incyte Reports EC Approval of Opzelura (Ruxolitinib) Cream for Moderate Atopic Dermatitis

Shots: The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…
2 days ago

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NEWS

Ipsen to Acquire Kartos Therapeutics for ~$1.75B

Shots: Ipsen has entered into a definitive merger agreement to acquire Kartos Therapeutics, incl. its asset, navtemadlin, expanding its hemato-oncology late-stage pipeline As per the deal, Ipsen will acquire Kartos Therapeutics through a fully-owned subsidiary for $450M upfront & ~$1.3B in milestones, incl. a significant regulatory approval milestone & sales-based milestones; closing is expected by…
June 29, 2026

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Incyte
NEWS

Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

Shots: The P-III (TRuE-AD4) study assessed Incyte's Opzelura cream (BID) vs vehicle in 241 adults with mod. AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) & calcineurin inhibitors (TCIs); data presented at EADV’26 As previously reported, the study met its co-1EPs, with 83.5% pts achieving EASI75 & 74.4% reaching IGA-TS, while 74.3% pts…
May 8, 2026

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Incyte
NEWS

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…
September 19, 2025

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Incyte
NEWS

Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025

Shots: Incyte has reported P-III (TRuE-PN: TRuE-PN1 & TRuE-PN2) clinical program data assessing Opzelura (BID) vs vehicle in ~180 PN pts (≥18yrs.) each for 12wks TRuE-PN1 showed ≥4-point WI-NRS4 improvement at 12wks. (1EP; 44.6% vs 20.6%), with itch relief by Day 7 (22.4% vs 8.0%). It also met its 2EPs, incl. higher IGA-CPG-S-TS score…
March 10, 2025

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Insights+: EMA Marketing Authorization of New Drugs in February 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…
March 23, 2023

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