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The FDA has pushed the pause button on Sanofi’s and Lexicon’s diabetes treatment Zynquista (sotagliflozin) two months after an advisory committee panel deadlocked over the drug’s safety profile. Read More
Drug sponsors who want to use natural histories to help develop treatments for rare diseases should draw up well-defined statistical analysis plans and probably even hire statisticians to help develop the histories, the FDA said in new draft guidance issued Friday. Read More
The decision is another blow for Pfizer, which saw claims of a separate Prevnar 13 patent invalidated following several inter partes reviews in 2017. Read More
The FDA said it will allow drugmakers to sell losartan with higher levels of a potentially cancerous impurity over the next six months to prevent a shortage of the blood pressure drug. Read More