| Date | Title | Description |
| 16.03.2026 | Celltrion announces U.S. availability of AVTOZMA® (tocilizumab-anoh) subcutaneous (SC) formulation | AVTOZMA® (tocilizumab-anoh) is among the first wave of tocilizumab biosimilars with both intravenous (IV) and subcutaneous (SC) formulations approved and commercially available in the United States
The launch of AVTOZMA SC further diversifi... |
| 03.12.2025 | Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR® | FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases
... |
| 26.11.2025 | Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA® (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinic... | Findings from the post-hoc analysis of LIBERTY-CD study indicates efficacy of ZYMFENTRA® (subcutaneous infliximab) regardless of disease location, consistent across ileum-dominant and colon-dominant Crohn's disease (CD)
Findings support the... |
| 30.10.2025 | 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 interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 2... |
| 17.10.2025 | 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 pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S.[1],[2]
Pediatric UV is a rare eye inflammati... |
| 10.10.2025 | 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 degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR)
Celltrion... |
| 02.10.2025 | 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 FDA to treat the same conditions as the reference product ACTEMRA® (tocilizumab)
AVTOZMA is Celltrion's fifth immunology biologic and seventh b... |
| 06.08.2025 | 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 of adults and pediatric patients aged 2 years and older with cytokine release syndrome (CRS) [1]
AVTOMZA received FDA approval in January 2025, ... |
| 08.07.2025 | 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 indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2]
STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLI... |
| 19.06.2025 | Big Pharma Under Fire: A Taxing Debate in the Senate | The Senate floor is heating up. Two Democratic lawmakers, Sen. Elizabeth Warren and Rep. Jan Schakowsky, are shining a spotlight on the pharmaceutical giants. Pfizer, Johnson & Johnson, Merck, AbbVie, and Amgen are in the crosshairs. Th... |
| 16.06.2025 | 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 flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg
The FDA previously approved STEQEYMA® 45m... |
| 26.05.2025 | YUFLYMA®: A Game Changer in the Biosimilar Landscape | In the ever-evolving world of pharmaceuticals, the recent announcement from Celltrion, Inc. has sent ripples through the biosimilar market. The U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for ... |
| 24.05.2025 | 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 Humira® (adalimumab) biosimilar[1]
Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled s... |
| 22.05.2025 | 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 Humira® (adalimumab) biosimilar[1]
Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled s... |
| 28.04.2025 | 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 ZYMFENTRA® (infliximab-dyyb)
Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcera... |
| 31.03.2025 | Bridging Innovation and Accessibility: The New Era of AI and Healthcare Solutions | In the fast-paced world of technology and healthcare, two recent developments stand out. One is the appointment of Ajay Anand at the Wharton School, focusing on artificial intelligence (AI) and analytics. The other is the introduction of Ce... |
| 27.03.2025 | 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 launched on March 12, 2025
Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024
JERSEY CITY, N.... |
| 13.03.2025 | 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.
Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale acquisition cost (WAC) list price at an 85% discount... |
| 10.03.2025 | 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 the FDA
Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the ref... |
| 04.03.2025 | 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 indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2]
The FDA approval is based on robust clinical evidence, w... |
| 18.12.2024 | 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) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC)
STEQEYMA is a strategic addition to... |
| 19.11.2024 | Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocili... | 78-Week results from Phase III randomized controlled trial (RCT) including switching data from reference denosumab to CT-P41 (biosimilar candidate of denosumab) demonstrate comparable efficacy and safety results; Results support the therape... |
| 05.11.2024 | A New Dawn in Diabetes Management: Sigrid Therapeutics' SiPore21® Gel | In the realm of diabetes management, a new contender is emerging. Sigrid Therapeutics has just crossed a significant milestone with its SHINE clinical trial, which evaluated the SiPore21® gel. This innovative treatment aims to provide susta... |
| 30.10.2024 | 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 of subcutaneous (SC) infliximab over placebo for maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC)[1], [2]
ZYM... |
| 29.08.2024 | A New Era in Treatment: Celltrion USA's ZYMFENTRA® Partnership with Cigna and Express Scripts | In the ever-evolving landscape of healthcare, partnerships can pave the way for innovation and accessibility. Celltrion USA has recently made headlines by teaming up with Cigna Healthcare and Express Scripts. This collaboration aims to broa... |
| 29.08.2024 | Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit form... | JERSEY CITY, N.J., Aug. 29, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the pharmacy benefits services busine... |
| 28.08.2024 | Celltrion USA partners with Express Scripts and Cigna Healthcare to expand access to ZYMFENTRA® (infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab on their medical benefit form... | JERSEY CITY, N.J., Aug. 28, 2024 /PRNewswire/ -- Celltrion USA announced today that it has signed an agreement with Cigna Healthcare, the health benefits provider of the Cigna Group and Express Scripts, the pharmacy benefits services busine... |
| 13.08.2024 | Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program | Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023
Adalimumab-aaty's inclusion creates greater accessibility to tre... |
| 12.08.2024 | Celltrion USA announces incorporation of adalimumab-aaty, a Humira® biosimilar, to the Costco Member Prescription Program | Adalimumab-aaty was first approved by the Food and Drug Administration on May 23, 2023 and became commercially available among key distributors across the U.S. on July 2, 2023
Adalimumab-aaty's inclusion creates greater accessibility to tre... |
| 27.07.2024 | JPA Health's Strategic Leap: A New Era with akt Health Communications | In the fast-paced world of healthcare communications, JPA Health has made a bold move. The independent agency, known for its full-service offerings, has acquired akt health, a London-based communications powerhouse. This acquisition, announ... |
| 22.07.2024 | JPA Health Expands Global Presence with Acquisition of Award-Winning akt health communications, based in London | WASHINGTON, July 22, 2024 /PRNewswire/ -- JPA Health, an independent, full-service agency working exclusively in the health sector, announced the acquisition of London-based akt health, an award-winning communications agency recognized for ... |
| 22.07.2024 | JPA Health Expands Global Presence acquiring akt health communications | JPA Health, an independent, full-service agency working exclusively in the health sector, announced the acquisition of London-based akt health, an award-winning communications agency recognized for its work in delivering excellence across p... |
| 01.07.2024 | JPA Health Bolsters Leadership Team with the Appointment of Colleen Carter as Head of Life Sciences and Adam Pawluk as Head of JPA Labs | WASHINGTON, July 1, 2024 /PRNewswire/ -- JPA Health, an independent, full-service agency working exclusively in the health sector, today announces the expansion of its leadership team with the strategic appointments of Colleen Carter as Hea... |
| 24.05.2024 | JPA HEALTH EXPANDS CAPABILITIES WITH THE ACQUISITION OF BIOCENTRIC, INC. | This strategic acquisition combines BioCentric's medical affairs and commercial expertise with JPA Health's integrated services, predictive analytics and AI-driven solutions
WASHINGTON, May 24, 2024 /PRNewswire/ -- JPA Health, a global full... |
| 01.11.2023 | New 'One World, One Health' Report Shows Critical Need for Closer Collaboration Between Key Stakeholders Across Human, Animal, and Environmental Health | JPA Health Unveils Connectability Score to Measure Relationships Between Key Audiences
WASHINGTON, Nov. 1, 2023 /PRNewswire/ -- A new report from JPA Health entitled, "One World, One Health: Exploring the Connectability between Human, ... |
| 04.05.2022 | Great Point Partners Invests in JPA Health, Leading Marketing Communications Agency | GREENWICH, Conn. and WASHINGTON (PRWEB) May 04, 2022
Today Great Point Partners (“GPP”), a Greenwich-based private investment firm focused on the health care industry, announced the growth recapitalization of JPA Health (“JPA” or the “Compa... |
| 03.11.2021 | Antios Therapeutics Raises $75 Million in a Series B-1 Funding to Advance Clinical Programs for HBV | Antios Therapeutics, Inc. (“Antios”), a clinical-stage biopharmaceutical company developing innovative therapies to treat and cure chronic hepatitis B virus (HBV), today announced the successful closing of a $75 million Series B-1 financing... |
| 12.10.2021 | eXciteOSA® Daytime Sleep Apnea Therapy Device Surpasses 50,000 Patient Session Milestone | Driving comfort and relief for patients with snoring and mild obstructive sleep apnea
BOSTON and LONDON–(BUSINESS WIRE)–October 12, 2021–
Signifier Medical Technologies Ltd, an innovator in the sleep-disordered breathing market, announced t... |
| 27.07.2021 | Signifier Medical Technologies Raises $35M in Series D Funding Round to Accelerate Commercialization of eXciteOSA Therapy | All the sessions from Transform 2021 are available on-demand now. Watch now.
BOSTON & LONDON–(BUSINESS WIRE)–July 27, 2021–
Signifier Medical Technologies Ltd, a pioneer in patient-friendly therapies for sleep disordered breathing, anno... |
| 27.07.2021 | Signifier Medical Technologies Raises $35M in Series D Funding Round to Accelerate Commercialization of eXciteOSA Therapy | BOSTON & LONDON–(BUSINESS WIRE)–July 27, 2021–
Signifier Medical Technologies Ltd, a pioneer in patient-friendly therapies for sleep disordered breathing, announced that it has successfully raised $35 million in its Series D capital rai... |
| 12.04.2021 | Xilio Therapeutics Strengthens Management Team with R&D Leadership Appointments | WALTHAM, Mass.--(BUSINESS WIRE)-- Xilio Therapeutics, a biotechnology company developing potent, tumor-selective immuno-oncology therapies for people living with cancer, today announced that Rónán O’Hagan, Ph.D., has been promoted to chief ... |
| 24.02.2021 | Xilio Therapeutics Raises $95 Million in Series C Financing to Advance Potent Tumor-Selective Immuno-Oncology Pipeline | February 24, 2021 06:00 AM Eastern Standard Time |
| - | Xilio Therapeutics Raises $95 Million in Series C Financing to Advance Potent Tumor-Selective Immuno-Oncology Pipeline | WALTHAM, Mass.--(BUSINESS WIRE)--Feb 24, 2021--
Xilio Therapeutics, a biotechnology company developing potent, tumor-selective immunotherapies for patients with cancer, today announced the successful closing of a $95 million Series C financ... |
| - | JPA Health Recognized by PRWeek as 2021 Outstanding Small Agency | WASHINGTON--(BUSINESS WIRE)--Mar 19, 2021--
JPA Health, a full-service agency specializing in public relations, marketing and advocacy, won the 2021 Outstanding Small Agency Award at PRWeek’s Annual Ceremony. This recognition comes after a ... |
