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FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and...
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023.
Despite a boom of new, cost-efficient options for chronic conditions, prescriber and patient concern over clinical benefit persists.
The past year has seen a multitude of FDA approvals, ranging from IL-23 and JAK inhibitors to biologics and subcutaneous treatment administrations, that have helped redefine what it means to treat IBD.
Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a non-binding MOU with Aurigene…