FDA

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Why Regulus Is Tanking

Regulus Therapeutics Inc. (NASDAQ: RGLS) saw its shares cut in half early Tuesday morning following news of a clinical hold from the U.S. Food and Drug Administration (FDA). The company ...
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Could This Be a Turning Point for Fate Therapeutics?

Shares of Fate Therapeutics Inc. (NASDAQ: FATE) saw a healthy gain early on Monday following a key U.S. Food and Drug Administration (FDA) approval. Looking at the stock performance in 2016, ...
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Does Whole Foods Face Systemic FDA Warnings?

Whole Foods Market Inc. (NASDAQ: WFM) is under fire by federal regulators after an inspection conducted back in February. By the looks of this, it could be tough for the ...
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clinical trials

Why Sarepta’s PDUFA Delay Is a Good Thing

Sarepta Therapeutics Inc. (NASDAQ: SRPT) shares saw a handy gain on Wednesday following an analyst upgrade. Janney Montgomery Scott has a Neutral rating on Sarepta but increased its fair value estimate to ...
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Theravance Gets FDA Nod on Vibativ

Theravance Biopharma Inc. (NASDAQ: TBPH) saw its share take a slight tick up on Monday morning following a U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA ...
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4 Major FDA Decisions Expected by June

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 ...
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3 Big Pharma Stocks With Credible Threats to Their Blockbusters

A pharmaceutical company could face a threat to one of its products for a number of reasons, ranging from an improved formulation, a new drug approval to simply a patent expiry and the ...
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Why This Isn’t the End of Catalyst Pharmaceuticals

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) saw its shares get halved just Tuesday morning alone, following a business update regarding its Lambert-Eaton myasthenic syndrome (LEMS) treatment. The company provided an update ...
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4 Companies That Have Destroyed Shareholders

As earnings season is underway, some analysts are expecting earnings disappointments going forward, as S&P Global Market Intelligence expects earnings for the S&P 500 to shrink by about 8% in ...
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Why TransEnterix Shares Are in Free Fall

TransEnterix Inc. (NYSEMKT: TRXC) watched its shares in free fall on Thursday morning following a devastating judgment by the U.S. Food and Drug Administration (FDA). The company announced after the markets ...
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Can BioMarin Make Treating Hemophilia More Affordable?

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) is ready to break above the $1 billion revenue barrier in 2016. This is a feat that marks a major hurdle for many biotech and emerging ...
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Are Analysts Realistic on Clovis Oncology Now?

Clovis Oncology Inc. (NASDAQ: CLVS) was down about 5% Tuesday and was down even more Wednesday after the Oncologic Drugs Advisory Committee voted against its lung cancer drug. The committee ...
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clinical trials

Is PTC Therapeutics on the Road to Recovery?

PTC Therapeutics Inc. (NASDAQ: PTCT) saw its shares jump late Friday morning on positive news on its nonsense mutation Duchenne muscular dystrophy (nmDMD) treatment. The company announced that the National Institute for ...
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inVentiv Files for IPO

inVentiv Group Holdings has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). No pricing details were mentioned in the filing, but ...
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Regeneron Rises on Positive Top-Line Results

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), in conjunction with Sanofi, released top-line results for its most recent late-stage study. The companies announced that two placebo-controlled Phase 3 studies evaluating investigational dupilumab ...
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