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EU Grants Conditional Approval for Roche’s One-Minute Subcutaneous Lunsumio in Follicular Lymphoma

Nov 21, 2025
Roche announced that the European Commission has granted conditional marketing authorisation for a new subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for adults with relapsed…
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Novartis to Build Major U.S. Manufacturing Hub in North Carolina

Nov 21, 2025
Novartis has announced a sweeping expansion of its U.S. operations, unveiling plans to establish a new flagship manufacturing hub in North Carolina that will feature full end-to-end…
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FDA Approves Expanded Dosing Options for Regeneron’s EYLEA HD in Retinal Diseases

Nov 21, 2025
Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved EYLEA HD (aflibercept) Injection 8 mg for treating macular edema following retinal vein…
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Moderna Expands U.S. Manufacturing with New Onshore Drug Product Facility

Nov 21, 2025
Moderna, Inc. has announced a major expansion of its U.S. manufacturing network with plans to bring Drug Product (DP) manufacturing to its Moderna Technology Center (MTC) in Norwood,…
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Merck’s Two-Drug HIV Regimen Meets Phase 3 Trial Goals

Nov 21, 2025
Merck announced positive topline results from a pivotal Phase 3 trial evaluating its once-daily, oral two-drug regimen doravirine/islatravir (DOR/ISL) in treatment-naïve adults with…
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EC Approves First Simponi Biosimilar Gobivaz in Europe

Nov 21, 2025
The European Commission has approved Alvotech and Advanz Pharma’s Gobivaz, the first biosimilar to Simponi (golimumab) authorized in the European Economic Area. The approval covers…
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FDA Approves Arrowhead’s REDEMPLO, the First siRNA Therapy for Familial Chylomicronemia Syndrome

Nov 20, 2025
Arrowhead Pharmaceuticals has secured a major regulatory milestone with the U.S. Food and Drug Administration’s approval of REDEMPLO (plozasiran), marking the company’s first…
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EU Approves First Subcutaneous Version of Keytruda for All Adult Indications

Nov 20, 2025
The European Commission has approved Merck’s new subcutaneous formulation of Keytruda, branded as KEYTRUDA SC, making it the first subcutaneous immune checkpoint inhibitor available in…
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LNP Innovation Surges as 5th LNP Summit Unveils 2026 Agenda

Nov 19, 2025
April 6-8, 2026 | Boston, MA – Against a backdrop of major industry acquisitions including AbbVie/Capstan Therapeutics, Eli Lilly & Co/Verve Therapeutics, and now BMS/Orbital…
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EU Approves First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis

Nov 19, 2025
The European Commission has approved Insmed’s BRINSUPRI (brensocatib 25 mg tablets) as the first and only authorized treatment for non-cystic fibrosis bronchiectasis (NCFB) in the…
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Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry.

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Press Releases

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