Cancer genomics company Personal Genome Diagnostics Inc. (PGDx) secured $103 million in a Series C financing round. Proceeds from the financial infusion will be used to expand the company’s tissue-based and liquid biopsy portfolio and its global commercial footprint to support growth.
The FDA greenlit Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN, a serious progression of systemic lupus erythematosus (SLE), a chronic, complex and autoimmune disease. The approval not only marks the first medication in the United States specifically approved for active LN, it also marks the first for Aurinia, which is headquartered in Canada and last year opened its 30,000 square-foot commercialization facility in the BioHealth Capital Region.
Viela Bio’s Uplizna™ Granted FDA Approval As Company’s First Commercial Product Viela Bio’s Uplizna™ (inebilizumab-cdon), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMOSD), was approved by the [….]
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 [….]
Viela Bio Receives U.S. FDA Breakthrough Therapy Designation for Inebilizumab for Treatment of Neuromyelitis Optica Spectrum Disorder
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, [….]
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 [….]