JD Supra13h
FDA Accepts BLA for Amneal’s Denosumab Biosimilars
Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars ...
Zacks Investment Research on MSN1d
Ionis Out-Licenses Rights for Rare Blood Cancer Drug to Ono
Ionis Pharmaceuticals IONS signed a license agreement with Japan-based Ono Pharmaceutical. Per the terms, Ono has acquired ...
Lupus Foundation of America8d
FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
PharmExec10d
FDA Accepts Biologics License Application for GSK’s Depemokimab for Asthma with Type 2 Inflammation and CRSwNP
In the SWIFT and ANCHOR trials, depemokimab demonstrated statistically significant reductions in nasal polyp size, ...
Yahoo Finance9d
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the ...
MPR3d
FDA to Review Depemokimab for Asthma With Eosinophilic Phenotype, CRSwNP
The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps ...
Morningstar9d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of ...