Cytogen Announces FDA Clears IND for CYT-500, a Monoclonal Antibody for the Treatment of Metastatic Hormone-Refractory (FinanzNachrichten)
PRINCETON, N.J., May 8 /PRNewswire-FirstCall/ -- Cytogen Corporation ( Nachrichten ) announced today the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for CYT-500, the company's lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). Cytogen expects to begin the first U.S. Phase I clinical trial of CYT-500 in patients

Medicis Announces FDA Approval of SOLODYN -- minocycline HCl, USP -- Extended Release Tablets (PrimeZone via Yahoo! Finance)
Medicis today announced that the U.S. Food and Drug Administration has approved its New Drug Application for SOLODYN Extended Release Tablets. SOLODYN is the only oral minocycline approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

cGMPs publication date set for December 2006 (Nutraingredients.com)
5/9/2006 - FDA has finally announced that publication of current good manufacturing practice for dietary supplements has been set for the end of 2006, but past disappointments have led an industry organization to consider self regulation as an alternative.