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Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV

Executive Summary

The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

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Janssen’s Newly Approved Ponvory Joins Crowded MS Space

Ponesimod is the fourth S1P modulator approved to treat multiple sclerosis and joins a sprawling class of oral and injectable therapies. But Janssen sees numerous ways to differentiate its drug.

Crunch Time For Idorsia Insomnia Therapy As Reviews Begin

The US FDA has accepted the Swiss biotech's "huge" NDA file for daridorexant which the company hopes will be more successful on the insomnia market than other DORA sleep treatments such as Merck & Co's Belsomra.

Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm

US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.

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