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Regulatory NEWS
A mixed but positive FDA advisory panel vote combined with the looming Oct. 24 PDUFA date cast into question whether NPS Pharmaceuticals Inc.'s recombinant human parathyroid hormone for hypoparathyroidism, Natpara, will be approved without delay.
Ahead of Friday's FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting, briefing materials have been posted related to the biologic license application (BLA) for Natpara (rhPTH[1-84]) developed by NPS Pharmaceuticals Inc., of Bedminster, N.J.
Keryx Biopharmaceuticals Inc.'s ferric citrate will go to market after approval Friday by the FDA, two days before the drug's Sunday PDUFA date. But the agency rescinded approval of the long-used trade name Zerenex, forcing the company to go back to the drawing board for a name that passes muster.
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