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GSK Seeks Expanded Use Approval from FDA for RSV Vaccine Arexvy

July 14th 2025

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

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Modeling Approaches for Determination of Pharmacokinetics/Pharmacodynamics

July 4th 2025

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Multiple Myeloma Treatment from Regeneron Gets FDA Accelerated Approval

July 2nd 2025

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EDQM Announces Digital Version of the European Pharmacopoeia

June 26th 2025

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EMA Conditionally Authorizes Stem Cell Therapy for Blood Cancers

June 23rd 2025

Digitalization of QbD Risk Assessments

The digital transformation of quality-by-design assessment workflows can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.

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