Complying with Mandates for Manufacture of Sterile Products
Maintaining traceability in pharmaceutical manufacturing processes is of utmost importance in navigating the intricate landscape of government regulations that influence
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Regulatory
Novavax Secures EC Approval for Updated 2024-2025 COVID-19 Vaccine
The leading global biotechnology company advancing protein-based vaccines, Novavax, announced that the European Commission has granted Marketing Authorisation for the
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Novavax Wins FDA Emergency Approval for 2024-2025 COVID-19 Vaccine Formula
Novavax, a global leader in protein-based vaccines, has announced that its updated COVID-19 vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705), has received
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FDA Approves Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 Vaccine
Pfizer and BioNTech have announced that the U.S. Food and Drug Administration (FDA) has approved their supplemental Biologics License Application
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ARS Pharmaceuticals’ EURneffy (Adrenaline Nasal Spray) Secures EC Approval
The European Commission has approved EURneffy®, the first and only needle-free adrenaline nasal spray, as an emergency treatment for allergic
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Celltrion’s Omlyclo Gets EC Green Light for Allergic Conditions
The approval is supported by robust clinical evidence, including results from a global Phase III trial. Omlyclo® is the first
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FDA Approves Pfizer’s BEQVEZ™ Gene Therapy for Hemophilia B
Pfizer announced on Friday that the U.S. FDA has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate
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FDA Approves J&J and Bristol Myers Cell Therapies for Refractory Multiple Myeloma
The U.S. Food and Drug Administration has approved the use of cell therapies developed by Johnson & Johnson (JNJ.N) and Bristol Myers Squibb (BMY.N) for treating
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US FDA Approves First Tumor-agnostic HER2-directed Therapy
The US FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as the first tumor-agnostic HER2-directed therapy for the
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FDA Greenlights Iovance’s AMTAGVI™ as First T-cell Therapy for Solid Tumor Cancer
Iovance Biotherapeutics, Inc., a leading biotechnology firm specialising in pioneering, developing, and delivering advanced polyclonal tumor infiltrating lymphocyte (TIL) cell
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