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CDSCO Clears Over 100 rDNA Drugs and Biologics Between 2020-25, Boosting Access to Advanced Therapies
23 Jan 2026 13:52 GMT
… autoimmune diseases) and advanced vaccines, revolutionizing treatment for many chronic and … M/s Epygen Biotech Private Limited
21-05- … M/s Sun
Pharmaceutical Industries Limited
24-03- … /23/000047
Golimumab Drug Substance (Bulk)
NA
Concentration: …
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Real-Life Use of Subcutaneous Biologicals and JAK Inhibitors in IBD Maintenance Therapy: Treatment Continuation, Switching Patterns, and Concomitant Medications
22 Jan 2026 16:54 GMT
… the use of conventional medications, treatment continuation, switching patterns, … switched from were golimumab (28% of golimumab treatment periods), tofacitinib … a prospective randomised trial. Gut. 2020;69 … data from clinical trials. Am J Gastroenterol …
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FDA Drug Approvals Q(4) 2025
20 Jan 2026 22:25 GMT
… lipid therapies (eg, statins, ezetimibe). Lerodalcibep reduced … 1 and SWIFT-2 trials. Among 762 patients … approvals
Simponi (golimumab)– Approved for the treatment of children … adjunctive therapy with antidepressants for treatment of major depressive …
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From Methotrexate Resistance to Biologic and Targeted Pharmacotherapy: A Decade of Phase 4 Clinical Trials Evidence in Rheumatoid Arthritis
08 Jan 2026 14:03 GMT
… , etanercept, adalimumab, golimumab, and certolizumab pegol … trials and provide important insight into emerging precision medicine … resistant RA.
Vaccination and adjunctive treatment studies broadened the … in rheumatoid arthritis. Pharmaceuticals. 2023;16(3): …
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Icelandic BioTech Alvotech secures €100 million term loan facility to bolster liquidity and R&D investment
02 Jan 2026 07:45 GMT
… BioTech company specialising in the development and manufacture of biosimilar medicines … an existing approved biologic medicine, or reference product. Biosimilars … adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®…
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Denosumab, Golimumab Biosimilars Clear Major Regulatory Milestones in Europe, as US Hurdles Remain
17 Dec 2025 01:47 GMT
… .
In parallel, Teva Pharmaceutical Industries also received EC … the Committee for Medicinal Products for Human Use … product launches provided additional treatment options for healthcare … authorizations for Gobivaz (golimumab), a biosimilar to Simponi …
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Human medicines European public assessment report (EPAR): Gotenfia, golimumab, Status: Opinion
12 Dec 2025 19:58 GMT
… (TNF-α) inhibitor (ATC code: L04AB06). Golimumab is a human monoclonal antibody … -inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Gotenfia is indicated for treatment of … to or have medical contraindications for such therapies.
Treatment with Gotenfia is …
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 December 2025
12 Dec 2025 19:06 GMT
… for Mnexspike (COVID-19 mRNA vaccine), for the prevention of COVID … opinions for two biosimilar medicines:
Gotenfia (golimumab), for the treatment of rheumatoid arthritis … Anavex (blarcamesine), a medicine intended for the treatment of Alzheimer’s disease …
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<![CDATA[FDA Approves Golimumab for Treatment of Pediatric Ulcerative Colitis]]>
09 Oct 2025 01:14 GMT
… Drug Administration (FDA) approved golimumab (Simponi; Johnson & Johnson) for the treatment … also consistent with clinical trials evaluating golimumab in adults.1, … Gasink, MD, vice president, medical affairs, gastroenterology & autoantibody, …
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Tumor Necrosis Factor Inhibitor Drugs Industry Analysis Report 2025: Key Trends, Drivers, and Forecast Insights
24 Nov 2025 00:00 GMT
… FDA approvals, a rise in disease incidence, clinical research and trials … inhibitor drugs are utilized in the treatment of … Pharmaceuticals, a company based in the US, collaborated with a biotechnology … Simponi Aria: Simponi (golimumab), Simponi Aria
5) …
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