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Intra-Cellular Stumbles Over Late-Stage Results

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) saw its shares absolutely crash on Thursday following the results from its late-stage schizophrenia trial. The company announced the top-line results from its Phase 3 clinical ...
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New Crohn’s Disease Drug Approved by FDA

Johnson & Johnson (NYSE: JNJ) is often not very vocal about receiving drug approvals, at least not using its own name. Janssen Biotech, a unit of Johnson & Johnson's Janssen ...
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How Much Will Consumers Save on New Humira Biosimilar?

Some interesting news that hit late last week may have been much larger news had not been going into the weekend. In a time when government wrangling about drug prices ...
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Could Puma Biotech Double After This FDA Approval?

Puma Biotechnology Inc. (NYSE: PBYI) posted strong gains over the course of this past week, which began with some positive news from the U.S. Food and Drug Administration (FDA) and ...
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Why Key Analyst Sees Puma Biotech Practically Doubling

Puma Biotechnology Inc. (NYSE: PBYI) has made solid gains over the course of this week, starting with some positive news from the U.S. Food and Drug Administration (FDA), but now ...
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How Sarepta Is Cashing In on Its FDA Homerun

Sarepta Therapeutics Inc. (NASDAQ: SRPT) watched its stock practically double in just the past week alone following a key FDA approval. There were a few factors that played into this ...
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Puma Biotech Rises on Key FDA Approval

Shares of Puma Biotechnology Inc. (NYSE: PBYI) had a strong gain in Tuesday’s session following some positive news from the U.S. Food and Drug Administration (FDA). The regulatory body announced that ...
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Sarepta Scores Big on Highly Contested FDA Approval

Sarepta Therapeutics Inc. (NASDAQ: SRPT) is clearing another hurdle related to its Duchenne muscular dystrophy (DMD) treatment, eteplirsen. The stock practically doubled on Monday following the U.S. Food and Drug ...
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Why This FDA Departure Is Huge for Sarepta

Sarepta Therapeutics Inc. (NASDAQ: SRPT) closed out Wednesday with its shares up over 25% following positive developments surrounding eteplirsen, its treatment of Duchenne muscular dystrophy. Although this development is not ...
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Key FDA Decisions and Trial Results Coming in the Next 2 Months

U.S. Food and Drug Administration (FDA) rulings and the results from clinical trials have proven time and again that they can make or break companies. The biotech and pharmaceutical ...
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Key FDA Decisions and Trial Results Expected in October

Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair to a great amount of ...
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Did Agios Just Speed Up Its Business Plan by 2 Years?

Celgene Corp. (NASDAQ: CELG) is making a move out of left field that has sent shares of its partner Agios Pharmaceuticals Inc. (NASDAQ: AGIO) significantly higher. In a surprise move, Celgene is ...
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Is the FDA Changing Its Tune on Evoke Pharma?

Evoke Pharma Inc. (NASDAQ: EVOK) made a handy gain in Wednesday’s session following a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). Coming out of this ...
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8 Major FDA Decisions and Trial Results to Watch for in September

Pharmaceutical and biotech 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 ...
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How Analysts and Investors Are Chasing Clovis Higher and Higher, All Over Again

Clovis Oncology Inc. (NASDAQ: CLVS) posted a massive gain of 27% to $23.03 on Tuesday, on the heels of news that the Food and Drug Administration (FDA) had granted it ...
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