AbbVie Announces European Commission Approval of RINVOQ … – AbbVie
Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn's disease
Third gastroenterology indication approved across AbbVie's Inflammatory Bowel Disease portfolio in less than a year
A significantly higher proportion of patients treated with RINVOQ achieved the co-primary endpoints of endoscopic response and clinical remission and the key secondary endpoint of corticosteroid-free clinical remission at weeks 12 and 52 compared to placebo1-4; safety results in Crohn's disease were generally consistent with the known safety profile of RINVOQ1,5-9
Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract and is progressive, potentially producing complications that require urgent medical care, including surgery10,11
NORTH CHICAGO, Ill., April 17, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the European Commission (EC) approved RINVOQ (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.1-4
"The EC approval of RINVOQ in Crohn's disease is a significant milestone in offering patients the first and only once-daily oral treatment that can provide endoscopic improvement, and sustained symptom relief, making a difference in their daily lives," saidThomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "With existing therapies, not all patients are able to achieve adequate disease control to meet their treatment goals, which is why we continue to embrace the challenge of expanding our IBD portfolio with new treatment options."
The EC approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.1-4
Co-Primary Endpoint Results from the Phase 3 program include1-4:
Key Secondary and Additional Endpoints include:
"Crohn's disease is a burden that can present patients with daily, often uncomfortable challenges,"saidLaurent Peyrin-Biroulet, M.D., Ph.D., professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France."These studies demonstrated RINVOQ's ability to achieve key treatment targets, including endoscopic outcomes and symptomatic relief, that are critical for patients and beneficial for long-term care."
The safety profile of RINVOQ in Crohn's disease was generally consistent with the known safety profile of RINVOQ.1-4Similar rates of serious adverse events including serious infections, were observed between patients receiving RINVOQ and placebo.1-4 The most common adverse events included nasopharyngitis, acne and COVID-19 in the RINVOQ treatment group.1-4 Reports of malignancy, major cardiovascular events, venous thromboembolic events and gastrointestinal perforation were infrequently observed (<1.0 Events/100 Patient-Years).
RINVOQ is approved in the EU for the treatment of adults with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, adults and adolescents with atopic dermatitis and now Crohn's disease.1,5-9
About Crohn's DiseaseCrohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.10,11It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.10,11Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the diseasenot only physically, but also emotionally and economically.10,11
About the U-EXCEED and U-EXCEL Inductions Studies, and the U-ENDURE Maintenance Study1-4The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of RINVOQ 45 mg as induction therapy and RINVOQ 15 mg and 30 mg as maintenance therapy in patients with moderately to severely active Crohn's disease. Topline results of the U-EXCEED and U-EXCEL induction studies were announced in December 2021and February 2022. Topline results of the U-ENDURE maintenance study were announced in May 2022. More information can be found onwww.clinicaltrials.gov(U-EXCEED:NCT03345836 , U-EXCEL:NCT03345849 , U-ENDURE:NCT03345823).
About RINVOQ (upadacitinib)Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible Janus Kinase (JAK) inhibitor.1 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.1
Phase 3 trials of upadacitinib (RINVOQ) in giant cell arteritis and Takayasu arteritis are ongoing.1,12-14
EU Indications and Important Safety Information about RINVOQ (upadacitinib)1
Indications
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
RINVOQ is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.
Ulcerative colitis
RINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Crohn's disease
RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.
Important Safety Information
ContraindicationsRINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Special warnings and precautions for useRINVOQ should only be used if no suitable treatment alternatives are available in patients:
Use in patients 65 years of age and olderConsidering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age, as observed in a large randomised study of tofacitinib (another JAK inhibitor), RINVOQ should only be used in these patients if no suitable treatment alternatives are available. In patients 65 years of age, there is an increased risk of adverse reactions with RINVOQ 30 mg once daily. Consequently, the recommended dose for long-term use in this patient population is 15 mg once daily.
Immunosuppressive medicinal products Use in combination with other potent immunosuppressants is not recommended.
Serious infectionsSerious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis and sepsis have been reported with RINVOQ. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported. RINVOQ should not be initiated in patients with an active, serious infection, including localized infections. RINVOQ should be interrupted if a patient develops a serious or opportunistic infection until the infection is controlled. A higher rate of serious infections was observed with RINVOQ 30 mg compared to 15 mg. As there is a higher incidence of infections in the elderly and patients with diabetes in general, caution should be used when treating these populations. In patients 65 years of age, RINVOQ should only be used if no suitable treatment alternatives are available.
TuberculosisPatients should be screened for TB before starting RINVOQ. RINVOQ should not be given to patients with active TB. Anti-TB therapy may be appropriate for select patients in consultation with a physician with expertise in the treatment of TB. Patients should be monitored for the development of signs and symptoms of TB.
Viral reactivationViral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with RINVOQ. Consider interruption of RINVOQ if the patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should occur before and during therapy. If hepatitis B virus DNA is detected, a liver specialist should be consulted.
VaccinationThe use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating RINVOQ, in agreement with current immunization guidelines.
Malignancy Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including RINVOQ. In a large randomised activecontrolled study of tofacitinib (another JAK inhibitor) in RA patients 50 years of age with 1 additional CV risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer (NMSC), was observed with tofacitinib compared to tumour necrosis factor (TNF) inhibitors. A higher rate of malignancies, including NMSC, was observed with RINVOQ 30 mg compared to 15 mg. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. In patients 65 years of age, patients who are current or past long-time smokers, or patients with other malignancy risk factors (e.g., current malignancy or history of malignancy), RINVOQ should only be used if no suitable treatment alternatives are available.
Hematological abnormalitiesTreatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.
Gastrointestinal PerforationsEvents of diverticulitis and gastrointestinal perforations have been reported in clinical trials and from postmarketing sources. RINVOQ should be used with caution in patients who may be at risk for gastrointestinal perforation (e.g., patients with diverticular disease, a history of diverticulitis, or who are taking nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or opioids. Patients with active Crohn's disease are at increased risk for developing intestinal perforation. Patients presenting with new onset abdominal signs and symptoms should be evaluated promptly for early identification of diverticulitis or gastrointestinal perforation.
Major adverse cardiovascular eventsMACE were observed in clinical studies of RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients 50 years of age with 1 additional CV risk factor, a higher rate of MACE, defined as CV death, non-fatal myocardial infarction and non-fatal stroke, was observed with tofacitinib compared to TNF inhibitors. Therefore, in patients 65 years of age, patients who are current or past long-time smokers, and patients with history of atherosclerotic CV disease or other CV risk factors, RINVOQ should only be used if no suitable treatment alternatives are available.
LipidsRINVOQ treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Hepatic transaminase elevationsTreatment with RINVOQ was associated with an increased incidence of liver enzyme elevation. If alanine transaminase (ALT) or aspartate transaminase (AST) increases are observed and drug-induced liver injury is suspected, RINVOQ should be interrupted until this diagnosis is excluded.
Venous thromboembolismEvents of deep venous thrombosis (DVT) and pulmonary embolism (PE) were observed in clinical trials for RINVOQ. In a large randomised active-controlled study of tofacitinib (another JAK inhibitor) in RA patients 50 years of age with 1 additional CV risk factor, a dosedependent higher rate of VTE including DVT and PE was observed with tofacitinib compared to TNF inhibitors. In patients with CV or malignancy risk factors, RINVOQ should only be used if no suitable treatment alternatives are available. In patients with known VTE risk factors other than CV or malignancy risk factors (e.g. previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, and inherited coagulation disorder), RINVOQ should be used with caution. Patients should be re-evaluated periodically to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue RINVOQ in patients with suspected VTE.
Hypersensitivity reactionsSerious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving RINVOQ. If a clinically significant hypersensitivity reaction occurs, discontinue RINVOQ and institute appropriate therapy.
Adverse reactions
The most commonly reported adverse reactions in RA, PsA, and axSpA clinical trials (2% of patients in at least one of the indications) with RINVOQ 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, ALT increased, bronchitis, nausea, neutropenia, cough, AST increased, and hypercholesterolemia. Overall, the safety profile observed in patients with psoriatic arthritis or active axial spondyloarthritis treated with RINVOQ 15 mg was consistent with the safety profile observed in patients with RA.
The most commonly reported adverse reactions in AD trials (2% of patients) with RINVOQ 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, blood CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza. Dose dependent increased risks of infection and herpes zoster were observed with RINVOQ. The safety profile for RINVOQ 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated.
The most commonly reported adverse reactions in the UC and CD trials (3% of patients) with RINVOQ 45mg, 30mg or 15mg were upper respiratory tract infection, pyrexia, blood CPK increased, anemia, headache, acne, herpes zoster, neutropaenia, rash, pneumonia, hypercholesterolemia, bronchitis, aspartate transaminase increased, fatigue, folliculitis, alanine transaminase increased, herpes simplex, and influenza.
The overall safety profile observed in patients with UC was generally consistent with that observed in patients with RA.
Overall, the safety profile observed in patients with CD treated with RINVOQ was consistent with the known safety profile for RINVOQ.
The most common serious adverse reactions were serious infections.
The safety profile of upadacitinib with longterm treatment was generally similar to the safety profile during the placebocontrolled period across indications.
This is not a complete summary of all safety information.
See RINVOQ full Summary of Product Characteristics (SmPC) at http://www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in GastroenterologyWith a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visithttps://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.
About AbbVieAbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,LinkedInorInstagram.
Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, uses of future or conditional verbs generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References:
* Endoscopic response is defined as a decrease in simple endoscopic score for Crohn's disease (SES-CD) of >50% from baseline (or at least a 2-point reduction from baseline in patients with a baseline score of 4) of the induction. Clinical remission per SF/AP is defined as average daily very soft or liquid stool frequency 2.8 AND abdominal pain score 1.0 and neither greater than baseline. Corticosteroid-free clinical remission is defined as discontinuation of corticosteroid and achievement of clinical remission among subjects on corticosteroid at baseline in the induction studies and is defined as without corticosteroid use for 90 days and achievement of clinical remission in the maintenance study. Mucosal healing is defined as SES-CD ulcerated surface subscore of 0 in patients with SES-CD ulcerated surface subscore 1 at baseline. Mucosal healing was a prespecified endpoint, not controlled for multiplicity.
SOURCE AbbVie
View post:
AbbVie Announces European Commission Approval of RINVOQ ... - AbbVie
- The European Union just issued a dire warning to its 450 million citizens: Stockpile supplies and prepare for disaster - Fortune - March 26th, 2025 [March 26th, 2025]
- The European Union is preparing for war and is calling for emergency reserves in every home - CiberCuba - March 26th, 2025 [March 26th, 2025]
- The European Union rejected Russias demand for a ceasefire in exchange for lifting sanctions - - March 26th, 2025 [March 26th, 2025]
- Exclusive | European Union to slap Meta with fine up to $1B or more for breaching strict antitrust rules: sources - New York Post - March 26th, 2025 [March 26th, 2025]
- Peter Rough sat down with Kaja Kallas, European Union high representative for foreign affairs and security policy and European Commission vice... - March 26th, 2025 [March 26th, 2025]
- Court of Justice of the European Union: Member states representatives appoint thirteen judges to the General Court - consilium.europa.eu - March 26th, 2025 [March 26th, 2025]
- When the European Union wants to get back to basics - Marketscreener.com - March 26th, 2025 [March 26th, 2025]
- The European Union urges citizens to stockpile supplies to last 3 days in case of crisis - Goshen News - March 26th, 2025 [March 26th, 2025]
- The European Union urges citizens to stockpile supplies to last 3 days in case of crisis - Oil City Derrick - March 26th, 2025 [March 26th, 2025]
- European Union's Transmission Shafts and Cranks Market Expected to Slightly Increase with a CAGR of +0.3% over the Next Decade - IndexBox, Inc. - March 26th, 2025 [March 26th, 2025]
- New European Union Plan To Boost Local Arms Production Would Freeze U.S. Out Of Billions - The War Zone - March 26th, 2025 [March 26th, 2025]
- European Union's Roasted Coffee Market to See Continued Growth with +0.6% CAGR by 2035 - IndexBox, Inc. - March 26th, 2025 [March 26th, 2025]
- EU Penalizes RPM And Other Vertical Conduct Violations - Cartels, Monopolies - European Union - Mondaq News Alerts - March 26th, 2025 [March 26th, 2025]
- European Union's Toilet Paper Market to Reach $27.1B by 2035 with +0.5% CAGR - IndexBox, Inc. - March 26th, 2025 [March 26th, 2025]
- European Union Delays Retaliatory Tariffs On U.S. ProductsIncluding Whiskey - Forbes - March 20th, 2025 [March 20th, 2025]
- ICC President visits Brussels, urges European Union to take immediate action to protect the Court - the International Criminal Court - March 20th, 2025 [March 20th, 2025]
- The European Sting is Your democratic, independent and top quality political newspaper specialized in European Union News. Unique Features: iSting... - March 20th, 2025 [March 20th, 2025]
- The Prime Minister of Slovakia supported Ukraine's integration into the European Union - Eurasia Daily - March 20th, 2025 [March 20th, 2025]
- Trump reacts to European Union slapping tariffs on U.S. goods - CBS News - March 13th, 2025 [March 13th, 2025]
- Rxulti approved in the European Union for adolescent schizophrenia - PharmaTimes - March 13th, 2025 [March 13th, 2025]
- European Union Responds With Tariffs on Soybeans, Other Ag Exports - DTN The Progressive Farmer - March 13th, 2025 [March 13th, 2025]
- European Union retaliates with tariffs on $28 billion U.S. products - RFD-TV - March 13th, 2025 [March 13th, 2025]
- Donald Trump threatens European Union with 200% tariffs on specific goods if they dont remove nasty tax - UNILAD - March 13th, 2025 [March 13th, 2025]
- Canada and the European Union announce retaliatory tariffs against the United States - KREM.com - March 13th, 2025 [March 13th, 2025]
- Commission decides to refer SPAIN to the Court of Justice of the European Union due to discriminatory tax treatment of non-resident taxpayers - The... - March 13th, 2025 [March 13th, 2025]
- European Union hits back with counter tariffs on US goods - USA TODAY - March 13th, 2025 [March 13th, 2025]
- Trade Wars: European Union Retaliates Against U.S. Tariffs on Steel and Aluminum - TipRanks - March 13th, 2025 [March 13th, 2025]
- Commission hosts event to gather input and expertise on upcoming European Water Resilience Strategy - European Union - March 7th, 2025 [March 7th, 2025]
- UNESCO and the European Union Promote Training in Creative Tourism in the Caribbean - UNESCO - March 7th, 2025 [March 7th, 2025]
- The Interests of the European Union and the United States Are Diverging - Modern Diplomacy - March 7th, 2025 [March 7th, 2025]
- Tunisia: Call for the European Union to send international observers to the so-called "conspiracy" trial - FIDH - March 7th, 2025 [March 7th, 2025]
- European Union Blasts Trump Tariff Threats as Starmer Visits White House - Newsweek - February 27th, 2025 [February 27th, 2025]
- Trump vows to slap 25% tariffs on the European Union - FRANCE 24 English - February 27th, 2025 [February 27th, 2025]
- Trump vows to impose 25% tariffs on imports from the European Union - The Associated Press - February 27th, 2025 [February 27th, 2025]
- Trump says tariff level will be 25% on European Union products - Le Monde - February 27th, 2025 [February 27th, 2025]
- EU reaffirms unwavering support to Ukraine on anniversary of invasion - European Union - February 27th, 2025 [February 27th, 2025]
- The European Union is financing a project to strengthen social protection for women in ten local communities in Bosnia and Herzegovina - EEAS - February 27th, 2025 [February 27th, 2025]
- Trump's reciprocal tariffs would hit these European Union products that Americans buy the hardest - CNBC - February 14th, 2025 [February 14th, 2025]
- European Union Says It Will Respond "Firmly, Immediately" To Trump's Tariffs - NDTV - February 14th, 2025 [February 14th, 2025]
- How the European Union could counter US tariffs - ING Think - February 14th, 2025 [February 14th, 2025]
- (Nemolizumab) Approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis - Business Wire - February 14th, 2025 [February 14th, 2025]
- European Union could ban the number 1 Catholic app in the world: Hallow - ZENIT - English - February 14th, 2025 [February 14th, 2025]
- Political contagion in Europe: can the European Union survive Trumpism? - Bruegel - January 19th, 2025 [January 19th, 2025]
- Bolstering the cybersecurity of the healthcare sector - European Union - January 19th, 2025 [January 19th, 2025]
- Medidatas Patient Experience Recognized as Sustainability Solution by the European Union, Paving the Way for Greener Clinical Trials - Dassault... - January 19th, 2025 [January 19th, 2025]
- European Union Special Representative for the Great Lakes Region, Johan Borgstam, makes first official visit to Tanzania - EEAS - January 19th, 2025 [January 19th, 2025]
- Indicating the way forward for sustainable European aviation - European Union - January 19th, 2025 [January 19th, 2025]
- UNHCR and the European Union join forces to provide lasting solutions for Afghan refugees and returnees - EEAS - January 19th, 2025 [January 19th, 2025]
- Irregular migration into the European Union fell sharply last year, border agency says - The Associated Press - January 19th, 2025 [January 19th, 2025]
- Poland Assumes the Presidency of the Council of the European Union - Kyiv Post - January 6th, 2025 [January 6th, 2025]
- Far From Ignorant: The European Union, Arms Exports and Israel - CounterPunch - January 3rd, 2025 [January 3rd, 2025]
- Major changes in the European Union - summary of 2024: everything you need to know in 2025 - Visit Ukraine - January 3rd, 2025 [January 3rd, 2025]
- Hungary's controversial presidency of the Council of the European Union comes to an end - Euronews - January 1st, 2025 [January 1st, 2025]
- 30 years together: Austria, Finland and Sweden in the EU - European Union - January 1st, 2025 [January 1st, 2025]
- AI and Employee Data Protection in the European Union: 8 Key Takeaways for Multinational Businesses - JD Supra - January 1st, 2025 [January 1st, 2025]
- Pro-European Union Protests in Georgia Continue into New Years Eve - AL24 News - January 1st, 2025 [January 1st, 2025]
- 2025, between the reformist drive and the structural challenges of the European Union - The Diplomat in Spain - January 1st, 2025 [January 1st, 2025]
- Statement on behalf of the European Union and its Member States by H.E. Ambassador Stavros Lambrinidis, Delegation of the European Union to the United... - December 30th, 2024 [December 30th, 2024]
- European Union to resume Association Council meetings with Israel - The Times of Israel - December 18th, 2024 [December 18th, 2024]
- Its time for the European Union to rethink personal social networking - Bruegel - December 18th, 2024 [December 18th, 2024]
- Mistral 3 project to receive 60 million from European Union - MBDA - December 18th, 2024 [December 18th, 2024]
- The European Union and Palestinian Authority convene Investment Platform and announce EUR 28.3 million of investments for the Palestine Financial... - December 18th, 2024 [December 18th, 2024]
- The EVERY Company Further Expands its IP Estate with European Union Patent for Recombinant Ovalbumin - Business Wire - December 18th, 2024 [December 18th, 2024]
- European Union sanctions 26 individuals and two entities in Belarus - euneighbourseast.eu - December 18th, 2024 [December 18th, 2024]
- European Union: What do CG&R companies need to know about the European Accessibility Act? - GlobalComplianceNews - December 18th, 2024 [December 18th, 2024]
- New EU norms to reduce environmental impact of smitheries and foundries - European Union - December 14th, 2024 [December 14th, 2024]
- Syria: Statement by the High Representative on behalf of the European Union on the fall of the Assad regime - consilium.europa.eu - December 10th, 2024 [December 10th, 2024]
- European Union and the Gates Foundation to co-host Gavi 6.0 High Level Pledging Summit - Bill & Melinda Gates Foundation - December 10th, 2024 [December 10th, 2024]
- European Union orders TikTok to preserve data related to Romanian election - The Associated Press - December 10th, 2024 [December 10th, 2024]
- European Union - United Republic of Tanzania: Joint Communique of the 2024 Partnership Dialogue - EEAS - December 10th, 2024 [December 10th, 2024]
- Human Rights Day: Statement by the High Representative on behalf of the European Union - consilium.europa.eu - December 10th, 2024 [December 10th, 2024]
- We are waiting to return home - helping refugees in Sudan - European Union - December 10th, 2024 [December 10th, 2024]
- Revised Regulation on Classification, Labelling and Packaging of Chemicals enters into force - European Union - December 10th, 2024 [December 10th, 2024]
- CCS legal framework for the development of carbon capture and storage technologies in Poland and the European Union - Dentons - December 10th, 2024 [December 10th, 2024]
- Mercosur and the European Union sign trade agreement - Fresh Fruit Portal - December 10th, 2024 [December 10th, 2024]
- European Union To Spend Over $4 Million And 3 Years To Create Report On European Animation Industry - Cartoon Brew - December 4th, 2024 [December 4th, 2024]
- Speech by President von der Leyen at the European Parliament Plenary on the new College of Commissioners and its programme - European Union - December 4th, 2024 [December 4th, 2024]
- ASSEMBLY | EU bishops reflect on Europes future and challenges of the new institutional cycle - The Catholic Church in the European Union - December 4th, 2024 [December 4th, 2024]
- Georgia suspends talks on joining the European Union and accuses the bloc of blackmail - The Associated Press - November 30th, 2024 [November 30th, 2024]
- An update on political advertising in the European Union - The Keyword - November 30th, 2024 [November 30th, 2024]