Fast Track news from FierceBiotech
NewsTalecris' antibody drug gets priority review
The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains Read more...
Accentia shares plunge on Phase III failure
Accentia Biopharmaceuticals disappointed its investors with a surprise announcement late Monday that a Phase III trial of SinuNase for chronic sinusitis had failed to hit its primary endpoint. The Read more...
Basilea shares plunge on antibiotic delay
Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA Read more...
Report: CellCyte stock up after promoter touts shares
After struggling for years to survive on angel investments, the Seattle Times reports that CellCyte Genetics has ridden a wave of hype this fall to push its market value to $440 million. And the Read more...
| Press ReleasesPRESS RELEASE: GTC Obtains FDA Fast Track Designation for ATryn GTC Obtains FDA Fast Track Designation for ATryn and Permission to Submit a Rolling BLA FRAMINGHAM, Mass. -- GTC Biotherapeutics announced today that the US Food and Drug Administration, or FDA, Read more... |
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