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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Tales From CMC Reviews: Norliqva, Hydroxychloroquine, Glycopyrrolate And Sotyktu
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.
Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings
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 Approved By FDA As Mallinckrodt Seeks To Advance New Business Strategy
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.