Latest FDA Special Protocol Assessment Stories

2014-02-13 08:30:49

WALTHAM, Mass., Feb. 13, 2014 /PRNewswire/ -- Syndax Pharmaceuticals, Inc., today announced that the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) has reached a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the planned pivotal Phase 3 trial of entinostat in patients with advanced breast cancer. The Phase 3 trial, expected to begin in the first half of this year, is intended to evaluate...

2014-01-17 08:23:10

Marketing Approval Triggers Milestone Payment to Keryx NEW YORK, Jan. 17, 2014 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that its Japanese partner, Japan Tobacco Inc. (JT), has received manufacturing and marketing approval of ferric citrate from the Japanese Ministry of Health, Labour and Welfare. Ferric citrate, to be marketed in Japan by JT's subsidiary, Torii Pharmaceutical Co., Ltd., under the brand name Riona(®), is indicated as an oral...

Word of the Day
  • A vial or small glass bottle, especially one for holding vinegar, oil, etc.; a caster for liquids.
This word is Middle English in origin, and ultimately comes from the Old French, diminutive of 'crue,' flask.