uniQure Announces FDA Removes Clinical Hold on Hemophilia B Gene Therapy Program

Read the full release here.uniQure, a leading gene therapy company advancing transformative therapies for patients with severe medical needs, announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Company’s hemophilia B gene therapy program after determining the Company satisfactorily addressed all issues identied by the FDA related to […]

US Food and Drug Administration's Drug Approval Process

What is a Drug, as Defined by the FDA? A drug is any product that is intended for the use in the diagnosis, cure, mitigation, treatmentor prevention of disease and is intended to affect the structure or any function of the body. Pre-Clinical Drug Sponsor’s Discovery and Screening Phase: Drug sponsor develops a new drug […]