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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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FDA Approves AbbVie’s EPKINLY Combination for Relapsed or Refractory Follicular Lymphoma

Nov 19, 2025
The U.S. Food and Drug Administration (FDA) has approved AbbVie’s EPKINLY® (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody, in combination with…
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Genprex Secures U.S. Patent Protecting REQORSA and PD-L1 Antibody Combination

Nov 19, 2025
Genprex, Inc. has strengthened the intellectual property protection surrounding its lead drug candidate, REQORSA® Gene Therapy, with the announcement that the U.S. Patent and Trademark…
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J&J to Acquire Halda Therapeutics in $3.05B Cancer Therapy Deal

Nov 19, 2025
Johnson & Johnson has announced a definitive agreement to acquire Halda Therapeutics OpCo, Inc., a clinical-stage biotechnology company developing next-generation targeted cancer…
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EMA Panel Backs High-Dose SPINRAZA Regimen for Spinal Muscular Atrophy

Nov 18, 2025
Biogen announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a unanimous positive opinion recommending approval of a high-dose…
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Johnson & Johnson to Acquire Halda Therapeutics for $3.05B to Expand Oncology Pipeline

Nov 18, 2025
Johnson & Johnson has announced a definitive agreement to acquire Halda Therapeutics, a clinical-stage biotech developing oral, targeted cancer therapies using its proprietary…
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Press Releases

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