FDA

Jefferies Sees Big Upside From 4 Upcoming Near-Term Biotech Catalysts

If there is one area that can generate riches for speculative investors, it would have to be biotech and emerging pharma. After all, how many companies can go from nothing ...
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Blockbuster Drug Imbruvica Gets Expanded FDA Approval for Chronic Graft Versus Host Disease

A blockbuster drug is about to get a chance to have even higher sales. The U.S. Food and Drug Administration (FDA) has expanded its approval of Imbruvica for the treatment ...
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Gilead Secures FDA Approval For Chronic Hepatitis C Re-Treatment

Gilead Sciences, Inc. (NASDAQ: GILD) shares remained unchanged after the firm announced an approval from the U.S. Food and Drug Administration (FDA). Essentially, the FDA approved Vosevi (sofosbuvir 400 mg/velpatasvir ...
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Puma Biotech Wins Big on FDA Approval of Breast Cancer Treatment

 Shares of Puma Biotechnology, Inc. (NASDAQ: PBYI) touched a multiyear high Tuesday after the company reported a key approval by the U.S. Food and Drug Administration (FDA). Specifically, the agency ...
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Why Ocular Therapeutix Shares Are Getting Crushed

Ocular Therapeutix Inc. (NASDAQ: OCUL) shares were absolutely crushed on Wednesday after the firm received less than favorable news from the U.S. Food and Drug Administration (FDA). In effect, the ...
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FDA Issues an Approval Not Seen in Almost 20 Years

In an incredible move on Friday, the U.S. Food and Drug Administration (FDA) approved Endari for the treatment of patients age five and older with sickle cell disease to reduce ...
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Cara Therapeutics Wins Big on FDA Breakthrough

Cara Therapeutics Inc. (NASDAQ: CARA) saw its shares make a handy gain on Friday after the company said that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy ...
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Rigel Pharma Rises Following FDA Approval

Shares of Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) saw a handy uptick on Monday after the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for the use ...
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How Omeros Won Big on This FDA Approval

Omeros Corp. (NASDAQ: OMER) saw its shares make a handy gain on Tuesday after the company announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy designation ...
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Why Akebia Shares Are Hitting New Highs

Akebia Therapeutics Inc. (NASDAQ: AKBA) saw its shares hit a new 52-week high in Tuesday’s session following a key licensing agreement with Vifor Pharma. Specifically this is an exclusive license ...
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Merck’s Accelerated Keytruda Lung Cancer Approval Creates 3 Moves

It is no secret that pharma and biotech shares have had to deal with at least some headwinds over the past year. It turns out that drug pricing concerns and ...
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Did Immunomedics Rise Too Much as Seattle Genetics Deal Terminated?

Shares of Immunomedics Inc. (NASDAQ: IMMU) saw a massive gain on Friday after the company announced the termination of its licensing deal with Seattle Genetics Inc. (NASDAQ: SGEN). It may seem ...
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Intra-Cellular Therapies Sinks on FDA Update

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) saw its stock crumble early on Monday after the company provided an update on its plan to submit a New Drug Application (NDA) for ITI-007 ...
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FDA Delivers Big Rheumatoid Athritis Disappointment for Eli Lilly and Incyte

Big Pharma and Big Biotech sometimes live and die by actions out of the U.S. Food and Drug Administration (FDA). For Eli Lilly and Co. (NYSE: LLY) and Incyte Corp. (NASDAQ: ...
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Monday’s Top Biopharma Movers

A few biopharma stocks made massive runs on Monday morning. The broad markets are holding near their all-time highs, and part of the run up to this level is attributed ...
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