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Complete Response Letter (CRL)

Allergan has disclosed that it has received a complete response letter (CRL) from the US Food and Drug Administration indicating that it cannot approve the new drug application (NDA) submitted for ulipristal acetate. more

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Biopharmaceutical company focused on the development, manufacture and commercialisation of therapies for ocular conditions, Ocular Therapeutix, has received a complete response letter regarding its resubmission of a new drug application 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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The FDA has issued a complete response letter denying Merck’s application to include cardiovascular information on its drug labels for its diabetes drugs, Januvia and Janumet. more

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The US Food and Drug Administration (FDA) has rejected the first medication that combines drugs with a digital sensor that measures medication adherence more

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