FDA has four big drug decisions lined up
The next 5 or 6 weeks look big for potential new drug approvals. The FDA is slated to decide on Gilead Sciences' ($GILD) four-drug HIV med, Quad, on Aug. 27. Sometime this month it also is expected to make decisions on Pfizer's ($PFE) tofacitinib for rheumatoid arthritis and Sanofi's ($SNY) closely-watched Aubagio for multiple sclerosis, which Genzyme is shepherding through as keeper of the MS franchise. Perhaps most anxious is Ironwood Pharmaceuticals ($IRWD), the Cambridge, MA-based biotech that has spent 14 years working on the irritable bowel syndrome drug linaclotide. Its PDUFA is expected early in September. Story | More
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