Article: Pipeline previews.(new drug profiles)

Article: Review of Takeda's Febuxostat New Drug Application ...
Biotech Week;  February 4, 2009 ;     632 words ... ... will not be able to complete its review of the febuxostat New Drug Application (NDA) by the Prescription Drug User Fee Act ... routine inspections and look forward to receiving a final approval date for febuxostat." Febuxostat is currently under review with ...

Article: AstraZeneca's new-drug hopes to restore faith.
The Evening Standard (London, England);  October 6, 2004 ;     642 words ... ... near-term prospects. Follow-up studies on Galida have been extended for two years, pushing out the drug's possible approval date from 2006 and into 2007. McKillop is under pressure from the City to revive confidence in AstraZeneca's future drugs prospects ...

Article: Pipeline previews.
Journal of Drugs in Dermatology;  December 1, 2002 ;     700+ words ... ... SE5 to Original New Drug Application Approval Date: 17-JUL-02 Trade ... SE5 to Original New Drug Application Approval Date: 17-JUL-02 Trade ... SE8 to Original New Drug Application Approval Date: 07-JUN-02 Trade ...

Article: Avalere Health Compares FDA Review of Several Categories of Drugs ...
PR Newswire;  June 5, 2007 ;     700+ words ... ... when a drug passed a specific FDA review milestone (such as investigational new drug [IND] submission date, new drug application [NDA] submission date, approval date) to determine the length of time each product spent between review milestones ...

Article: Biotech Executives to Tell Congress: Fix OPPS With Proposed ...
PR Newswire;  April 7, 2003 ;     700+ words ... ... should be able to submit payment claims for a new drug or biologics from the FDA approval date. During a drug's first year on the market ... of millions of dollars it takes to develop a new drug or biologic. As Congress takes up the Medicare ...

Transcript: Profile: New drug studies show promising results ...
NPR All Things Considered;  January 1, 2003 ;     700+ words ...00-00-0000 Profile: New drug studies show promising results in treatment ... I'm Michele Norris. A single, new drug is showing promise against two very ... cramps, diarrhea and bleeding. But a new drug called natalizumab may offer more relief ...

Article: SFDA raises threshold for new drug applications.
China Business News;  July 11, 2007 ;     700+ words ...SFDA raises threshold for new drug applications Shanghai. July 11 ... Administration has raised the bar on new drug applications to encourage innovation ... longer necessarily qualify a drug for new drug status. Under previous registration ...