"The Pink Sheet" incorrectly identified the approval date for Novartis/QLT's Visudyne photodynamic therapy in a recent story (1"The Pink Sheet" July 25, 2005, p. 16). The therapy was approved in April 2000...
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Genentech could begin a rolling BLA filing for its neovascular (wet) age-related macular degeneration therapy Lucentis (ranibizumab) as early as December if the company is granted fast-track designation by FDA
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.