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biologics licence application

Biotech company, Roche, has announced that the US FDA has accepted its biologics licence application (BLA) and granted priority review for its once-weekly subcutaneous treatment for haemophilia A with factor VIII inhibitors more

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Pfizer has provided an update on its biologics licence application (BLA) for its proposed epoetin alfa biosimilar after receiving a complete response letter (CRL) from the US Food and Drug Administration (FDA). more

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Sanofi and Regeneron Pharmaceuticals has announced that the FDA has accepted the resubmission of the biologics licence application for Kevzara (sarilumab) as a Class I response with a two-month review timeline. more

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The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Sanofi and Regeneron Pharmaceuticals’ sarilumab more

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Genmab's licensing partner Janssen Biotech has initiated a rolling submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for daratumumab. more

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The reference product is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant. more