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Rilzabrutinib Receives Orphan Drug Designation for Two Rare Diseases

Apr 4, 2025
The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK)…
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Novartis Gets FDA Accelerated Approval for Vanrafia in IgAN

Apr 3, 2025
Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist,…
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Flagship Pioneering and Pfizer Partner to Develop Selective Inhibitors for Autoimmune Diseases

Apr 3, 2025
Flagship Pioneering announced an agreement between Pioneering Medicines, Flagship's in-house drug discovery and development unit, and Pfizer, to discover compounds which may lead to the…
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Astellas Partners with Japanese Cancer Foundation to Boost Oncology Research

Apr 3, 2025
Astellas Pharma Inc. and Japanese Foundation for Cancer Research announced they have entered into a strategic collaboration to accelerate translational and clinical oncology research.…
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EU Approves Pfizer’s RSV Vaccine ABRYSVO for Adults 18-59

Apr 2, 2025
Pfizer Inc. announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO, the company’s bivalent respiratory syncytial virus (RSV)…
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Apellis Gets FDA Priority Review for EMPAVELI in C3G, IC-MPGN

Apr 2, 2025
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation of the supplemental New Drug Application…
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AIRNA Secures $155M in Oversubscribed Series B for Alpha-1 Antitrypsin Trial

Apr 2, 2025
AIRNA, a biotech company pioneering RNA editing therapeutics to transform the lives of patients with rare and common conditions, announced the closing of an oversubscribed $155 million…
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Amneal Launches BORUZU, First Ready-to-Use Bortezomib Injection

Apr 2, 2025
Amneal Pharmaceuticals, Inc. and Shilpa Medicare Limited announced the U.S. launch of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous administration or…
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Bavarian Nordic Gets FDA Approval for Smallpox, Mpox Vaccine

Apr 1, 2025
Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating)…
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Qfitlia Approved as First US Therapy for Hemophilia A/B with or without Inhibitors

Apr 1, 2025
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of…
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Industry Reports

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Press Releases

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