Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection

Hologic announced that the U.S. Food and Drug Administration (FDA) has approved a diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay. The Aptima® HIV-1 Q…

Penumbra’s Newest Generation of Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism

Penumbra announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo® Aspiration System, Lightning™ 12. As part of the Indigo Aspiration…

ADC Therapeutics Announces FDA Accepts Biologics License Application and Grants Priority Review for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

ADC Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or re…

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

Pfizer and BioNTech announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against …

Alexion Receives Marketing Authorization from European Commission for New Formulation of ULTOMIRIS® (ravulizumab) with Significantly Reduced Infusion Time

Alexion Pharmaceuticals announced that the European Commission (EC) has approved the new 100 mg/mL intravenous (IV) formulation of ULTOMIRIS® (ravulizumab) for the treatment of two ultra-rare diseas…

Fujifilm Enters U.S. Surgical C-Arm and Radiographic Fluoroscopy Markets

FUJIFILM Medical Systems U.S.A., Inc., a leading provider of diagnostic imaging and medical informatics solutions, has entered the surgical and fluoroscopy markets with two new systems: the Persona C…

Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy

Novartis announced that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute r…
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