FDA Approvals - SmallCap Sentinel: Medical Milestones (PrimeNewswire via Yahoo! Finance) IRVINE, Calif.,
SmallCap Sentinel: Medical Milestones (PrimeNewswire via Yahoo! Finance)
IRVINE, Calif., June 21, 2007 -- "In a market populated by bold optimism and bright-eyed business plans, few companies ascend to the lofty precipice of FDA submissions and approvals," stated D.R.
Axcan Pharma Submits CMC Portion of its New Drug Application for ULTRASE and is Granted Fast Track Status (SYS-CON Media)
Axcan Pharma Inc. ("Axcan" or the "Company") (TSX: AXP)(NASDAQ: AXCA) today announced that it has filed the Chemistry, Manufacturing and Control data ("CMC") portion of its New Drug Application ("NDA") for ULTRASE in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), with the U.S. Food and Drug Administration ("FDA"). The Company plans to submit the complete and final NDA dossier to the ...
NKOFF: Subsidiary ACcomplishing Key Milestone Toward the FDA 510K Accreditation (Nasdaq)
NOVEKO INTERNATIONAL INC. announced that its subsidiary Noveko Inc. has accomplished the key milestone toward the FDA 510K accreditation of its two antimicrobial face masks: the Noveko 3xEZ and the 5dEZR.