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FDA Articles
Alkermes absolutely tanked early Thursday morning on less than favorable preliminary top-line results from the first two of three Phase 3 efficacy studies for ALKS 5461.
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Despite facing setbacks recently, Zafgen pushed ahead and led the bulls early on Wednesday on news of positive results.
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24/7 Wall St. has collected four companies big FDA decisions coming up in the first quarter of 2016 and added some color.
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Good news for those who suffer from high levels of uric acid and from gout: the FDA has approved a new gout treatment.
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Intercept Pharmaceuticals announced that the FDA has extended the PDUFA date for its Priority Review of obeticholic acid in primary biliary cholangitis.
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Advaxis has announced that the FDA has lifted the clinical hold on all of its Investigational New Drug (IND) applications for its three product candidates
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Pacira Pharmaceuticals announced that it achieved an amicable resolution with the FDA for a lawsuit filed earlier this year that effectively lifts the restriction on its Exparel.
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Neothetics Inc. (NASDAQ: NEOT) was absolutely crashed in Tuesday’s session after announcing top-line results from a late stage trial that fell short.
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AcelRx intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. However, this might be farther out than investors anticipated.
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Arena Pharmaceuticals saw its shares jump in Monday’s session on news of an U.S. Food and Drug Administration (FDA) approval.
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Pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a great amount of risk...
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Biotech company Can-Fite announced development of its drug candidate CF102, which is currently in phase 2 trials for liver cancer, will be expanded into treatment for non-alcoholic steatohepatitis.
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24/7 Wall St. has collected several big FDA decisions coming up in the month of November.
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courtesy of McDonald's Corp.Among the efforts McDonald’s (NYSE: MCD) is counting on to turn itself around is its “24 Hour Breakfast”, and a move to lower calorie, lower fat fast food than it...
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ThinkstockJanssen Biotech announced that the U.S. Food and Drug Administration (FDA) approved Yondelis (trabectedin) for the treatment of patients with unresectable or metastatic liposarcoma (LPS) or...
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