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FDA Approves First Gene Therapy for Broad SMA Patient Population

Nov 25, 2025
The U.S. Food and Drug Administration (FDA) has approved Novartis’ Itvisma® (onasemnogene abeparvovec-brve) for children aged two years and older, as well as teens and adults, living…
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Vaximm Enters Talks for Global License of Oral Cancer Therapy

Nov 24, 2025
OSR Holdings, Inc. announced that its subsidiary Vaximm AG has signed a non-binding term sheet with Swiss-based life sciences investment group BCM Europe AG (BCME) to evaluate a…
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AstraZeneca to Invest $2 Billion in Major Maryland Expansion

Nov 24, 2025
AstraZeneca announced plans to invest $2 billion to significantly expand its manufacturing presence in Maryland, marking one of the company’s largest U.S. investments to date. The…
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Alkermes Boosts Offer to Acquire Avadel in Deal Worth Up to $2.37 Billion

Nov 21, 2025
Alkermes plc and Avadel Pharmaceuticals have agreed to revised terms for Alkermes’ acquisition of Avadel, increasing the total potential value of the deal to $22.50 per share. The new…
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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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Industry Reports

Amgen Acquires Dark Blue to Advance Novel AML Treatments

Takeda Expands Entyvio Options Through Halozyme Technology…

Inductive Bio Wins $21M to Build AI Drug Toxicity Models

Alkermes Boosts Offer to Acquire Avadel in Deal Worth Up to…

Novartis Completes Acquisition of Tourmaline Bio to…

Press Releases

2nd T-Cell Engager for Autoimmune Disease Summit Returns in…

New Era for Autoimmune T-Cell Engagers Takes Centre Stage…

From Innovation to Acquisition: CrossBridge Bio’s ADC…

COPD Foundations Joins the COPD Drug Development Summit

Advancing Respiratory Medicine Following ATS – What Now?

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