FDA

Does Gilead’s CAR T Approval Vindicate the High Acquisition Price for Kite Pharma?

Gilead Sciences Inc. (NASDAQ: GILD) has seen many analysts raise their price targets in recent weeks, and now there is a new U.S. Food and Drug Administration (FDA) approval that ...
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Even More Biopharma and FDA Catalysts Coming in October

As the markets continue to hit all-time highs, biotech and pharmaceutical companies have been part of these massive gains. There is a very positive sentiment in the health care sector ...
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FDA Update Keeps Rigel Pharmaceuticals Above Water

Shares of Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) saw a solid gain to start off the week after the company gave an update from its meeting with the U.S. Food and ...
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Major Biotech, Pharma and FDA Catalysts Coming in October

Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a ...
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The List of Failed Alzheimer’s Drug Treatments Keeps Growing

If there is one cure or one treatment that could be the proverbial Holy Grail for a pharmaceutical or biotech company, it would be in a successful treatment of Alzheimer's ...
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FDA Crashes Down on Intercept’s Deadly Drug

Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) shares tumbled on Thursday after it came to light that the U.S. Food and Drug Administration (FDA) had issued a warning about the firm’s liver ...
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Can BioCryst Turn Itself Around With This FDA Approval?

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) saw its shares make a handy gain in Thursday's premarket after the firm received an update from the U.S. Food and Drug Administration (FDA). This ...
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Pluristem Wins Key FDA Approval

Shares of Pluristem Therapeutics Inc. (NASDAQ: PSTI) saw a handy gain early Monday after the company said it had received a key update from the U.S. Food and Drug Administration (FDA). Essentially the ...
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Celgene Faces Multiple Clinical Holds From FDA

Celgene Corp. (NASDAQ: CELG) received an update from the U.S. Food and Drug Administration (FDA) early on Thursday. Although shares did not dip initially, this action could prove to be ...
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How Insmed Is Capitalizing on Its Huge Late-Stage Success

Insmed Inc. (NASDAQ: INSM) kicked off this week with an incredible gain — the stock more than doubled on Tuesday — and now management is looking to capitalize on this ...
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FDA Crushes Cellectis With Clinical Hold

Cellectis S.A. (NASDAQ: CLLS) shares tumbled early on Tuesday after the firm announced that a couple of its early-stage studies in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell ...
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BioCryst Pharma Sees Brief Surge on Mid-Stage Trial Win

Shares of BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) saw a handy gain on Tuesday after the company released the final results from its mid-stage APeX-1 clinical trial in hereditary angioedema (HAE). ...
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FDA Crushes SteadyMed With Refusal to File Letter

SteadyMed Ltd. (NASDAQ: STDY) shares plummeted after the news that it had received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA). This is yet ...
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Ironwood Pharma Muted Despite FDA Approval

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) shares remained relatively muted on Monday after the firm announced a key U.S. Food and Drug Administration (FDA) approval for its gout treatment duzallo. The ...
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Valeant Pharmaceuticals Gets Boost From FDA Update

Shares of Valeant Pharmaceuticals International Inc. (NYSE: VRX) saw a handy gain on Thursday after the company provided an update from the U.S. Food and Drug Administration (FDA). Specifically, the ...
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