Regulatory

FDA
To date, Dupixent is the only biologic approved for this age group.
Alnylam Pharmaceuticals’ lumasiran for a chronic kidney stone disease was granted Priority Review status by the U.S. Food and Drug Administration. It will have a target action date of December 3, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration has a number of drug approvals on the calendar. Here’s a look.
FDA
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
FDA
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.
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