Two Frederick, Maryland MedTech Companies Receive FDA 510K Approvals

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Two Frederick, Maryland MedTech Companies Receive FDA 510K Approvals August 13, 2019 Frederick County, Maryland continues to be a vibrant hub for growing bioscience organizations. With its robust life science support ecosystem and proximity to key government research entities the region continues to produce and nurture exciting biotech companies across a wide range of fields, [….]

Viela Bio Receives U.S. FDA Breakthrough Therapy Designation for Inebilizumab for Treatment of Neuromyelitis Optica Spectrum Disorder

Viela Bio
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Viela Bio Receives U.S. FDA Breakthrough Therapy Designation for Inebilizumab for Treatment of Neuromyelitis Optica Spectrum Disorder Designation based on positive primary analysis of pivotal study, N-MOmentum Gaithersburg, MD—April 18, 2019 – Viela Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the Company’s anti-CD19 monoclonal antibody [….]

Leadiant Shows Rare Dedication to Patients With Recent FDA Approval of Revcovi™

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Leadiant Shows Rare Dedication to Patients With Recent FDA Approval of Revcovi™ November 20, 2018 Leadiant Biosciences, Inc. formerly known as Sigma-Tau Pharmaceuticals, recently received FDA approval for Revcovi™, which provides improved treatment for patients living with ADA-SCID, better known as “Bubble Boy Disease.” The journey that lead to Revcovi is a prime example of [….]