After nearly $1 billion and 27 years, S.F. biotech now must wait another 90 days for 1st FDA decision

A Food and Drug Administration decision on whether to approve a drug from FibroGen Inc. to treat anemia in chronic kidney disease patients was delayed Friday for 90 days. San Francisco-based FibroGen (NASDAQ: FGEN) and partner AstraZeneca plc (NASDAQ: AZN) expected a decision by Sunday, but the FDA said it required additional analyses of existing clinical trial results for the drug, called roxadustat. The agency moved the decision date to March 20. FibroGen CEO En rique Conterno said in a statement…
Source: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news