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Adaptimmune Receives Breakthrough Designation From FDA

Adaptimmune Therapeutics PLC (NASDAQ: ADAP) announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy designation for the company’s affinity enhanced T-cell therapy targeting NY-ESO in synovial ...
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Exelixis Rises on Positive Late-Stage Trial Results

Exelixis Inc. (NASDAQ: EXEL) was rising early Monday following the release of positive results from its late-stage trial of cabozantinib. The company announced positive overall survival (OS) results from METEOR, ...
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3 Key FDA Decisions Expected in February

Companies in the pharmaceutical industry are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, ...
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Relypsa Soars on Positive Phase 1 Results

Relypsa Inc. (NASDAQ: RLYP) rose early in Monday’s session as the result of positive results from its Phase 1 in vivo studies evaluating the interactions between Veltassa (patiromer) and other ...
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Why Alkermes Top-Line Results Might Not Be as Bad as Once Thought

Alkermes PLC (NASDAQ: ALKS) absolutely tanked early Thursday morning on less than favorable top-line results. The company announced preliminary top-line results from the first two of three Phase 3 efficacy ...
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Has a Zafgen Turnaround Begun?

Despite facing setbacks recently, Zafgen Inc. (NASDAQ: ZFGN) pushed ahead and led the bulls early on Wednesday on news of positive results. Some might even be wondering if this is ...
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4 Top FDA Decisions Expected in Q1

Pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount to a great amount of risk ...
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Why Breakthrough FDA Approval of Gout Treatment May Matter So Much

Good news for those who suffer from high levels of uric acid and from gout: the U.S. Food and Drug Administration (FDA) has approved a new gout treatment. AstraZeneca PLC ...
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Intercept Pharma Disappoints on FDA Extension

Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) lagged the markets on Friday morning as the result of an extension by the U.S. Food and Drug Administration (FDA). The company announced that the ...
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Advaxis Skyrockets on Resumed Clinical Trials

Advaxis Inc. (NASDAQ: ADXS) was absolutely running away early in Wednesday’s regular session on the release of an U.S. Food and Drug Administration (FDA) restriction. The company announced that the ...
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Pacira Pharma Soars on Settled FDA Case

Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) was leading the bulls in Tuesday’s session on positive news from the U.S. Food and Drug Administration (FDA). The company announced that it achieved an ...
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Why Neothetics Is Getting Destroyed

Neothetics Inc. (NASDAQ: NEOT) was absolutely crashed in Tuesday’s session after announcing top-line results from a late stage trial that fell short. The stock has fallen as far as to ...
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AcelRx Tanks on Pre-NDA Results

AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) made waves on Monday afternoon regarding the results from its pre-New Drug Agreement (NDA). The company reported on the outcome of the ARX-04 pre-NDA meeting ...
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Arena Pharma Soars on FDA Approval

Arena Pharmaceuticals Inc. (NASDAQ: ARNA) saw its shares jump in Monday’s session on news of an U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA has ...
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4 Key FDA Decisions Expected By Year End

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 ...
Read Full Story »