Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Insights from US drug approval packages include how CMP Development navigated inspection challenges, how Novitium built a better scientific bridge, how Fresenius Kabi delivered on leachables & extractables, and how BMS addressed dissolution.
Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.
Terlivaz is the first product approved to improve kidney function in adults with hepatorenal syndrome (HRS). The approval is a milestone in a long regulatory road for the drug.