Keeping Track: Shutdown Edition
The latest drug development news and highlights from our US FDA Performance Tracker.
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US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)
Ardelyx touts tenapanor's novel mechanism, favorable safety profile; advisory committee announcement reveals US Worldmeds’ bid to revive Novartis’ withdrawn Zelnorm.
Expanded Access Data Supported Lutathera Approval, US FDA Notes
Amid broader debate on right-to-try legislation, review experience of Novartis' oncologic highlights US FDA's argument that expanded access can at least in part contribute to approval of a drug.
Lutathera Approval Positions Novartis To Regain NET Share Taken By Ipsen
The US FDA has approved Advanced Accelerator Applications' radiopharmaceutical Lutathera to treat GEP-NETs second time around, just four days after Novartis closed its acquisition of AAA. The product should help the Swiss firm regain ground its Sandostatin product has lost to Ipsen's Somatuline.