Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
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Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.
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.