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Celltrion Inc.

Latest News

U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo)

* The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT®  (denosumab-bmwo) as interchangea...

2025-10-30 15:28 974

FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States

* YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pedi...

2025-10-17 13:32 1183

Celltrion receives U.S. FDA approval for EYDENZELT® (aflibercept-boav), biosimilar referencing EYLEA® (aflibercept)

* EYDENZELT® is approved for the treatment of patients with neovascular (wet) age-related macular...

2025-10-10 06:56 1342

Celltrion launches AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in the United States

* The AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation was approved in January 2025 by the...

2025-10-02 20:30 1643

FDA approves expanded indication for AVTOZMA® (tocilizumab-anoh) intravenous (IV) formulation in cytokine release syndrome (CRS)

* Approval of AVTOZMA® (tocilizumab-anoh) intravenous infusion expands label to include treatment...

2025-08-06 20:00 1821

Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)

* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indicatio...

2025-07-08 10:08 1897

Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients

* Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing...

2025-06-16 07:30 1809

Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths

* YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of H...

2025-05-24 01:47 4259

/DISREGARD RELEASE: Celltrion/

We are advised by Celltrion that journalists and other readers should disregard the news release, C...

2025-05-24 00:01 4129

Celltrion to present six abstracts in inflammatory bowel disease (IBD) at 2025 Digestive Disease Week® (DDW)

* Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ...

2025-04-28 20:00 2386

Celltrion's STEQEYMA® (ustekinumab-stba), now added to the Costco Member Prescription Program

* STEQEYMA® (ustekinumab-stba) is Celltrion's biosimilar to STELARA® (ustekinumab), which was lau...

2025-03-27 13:29 1920

STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), now available in the United States

* STEQEYMA®, one of the first-wave biosimilars to STELARA®, is now available in the U.S. * Appr...

2025-03-13 07:30 2186

U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

* OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by theFDA * R...

2025-03-10 07:16 2382

Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

* STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indicatio...

2025-03-04 12:28 2356

Celltrion unveils strategic vision for advancing its innovative drug pipeline at the 43rd Annual J.P. Morgan Healthcare Conference

* Celltrion unveils strategic roadmap for the first time outlining its innovative drug developmen...

2025-01-15 10:52 2636

U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab)

* STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO)...

2024-12-18 11:50 1572

ZYMFENTRA® (infliximab-dyyb) coverage continues to increase through partnership with top 3 Pharmacy Benefit Managers (PBMs)

* Celltrion USA has expanded access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-appro...

2024-10-31 14:31 1782

Celltrion presents post hoc analysis of LIBERTY studies of ZYMFENTRA®  (infliximab-dyyb) at the American College of Gastroenterology 2024 Annual Scientific Meeting

* Pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) previously demonstrated superior efficacy o...

2024-10-30 03:25 2127
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