FDA

Some Great News for Potential Alzheimer’s Treatment

It may be unusual to see a stock rise close to 100% without a corporate buyout, but in biotech and emerging pharmaceutical companies gains of that size can occur simply ...
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FDA Fast Track on Lung Cancer Treatment Brings Exponential Gains for This Microcap Stock

When companies see their shares rise by 100% or more in a single day, it's usually because of a buyout or an extremely positive change in a company's future prospects. ...
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This Week’s Biggest Biotech Movers

As the biotechnology group is pushing near all-time highs, this past week played host to a huge number of biotech movers. 24/7 Wall St. has picked a few of these ...
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What’s Next for Durect After FDA Posimir Vote

Durect Corp. (NASDAQ: DRRX) shares dropped early on Friday after the U.S. Food and Drug Administration Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) announced its vote on Posimir, the ...
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Why This Opioid Painkiller Is Killing Nektar Therapeutics Stock

Nektar Therapeutics (NASDAQ: NKTR) shares were crushed on Wednesday after the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management ...
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Does FDA Decision Mean a Bright Future for This Flu Vaccine?

Novavax Inc. (NASDAQ: NVAX) shares jumped on Wednesday after the U.S. Food and Drug Administration (FDA) granted a Fast Track Designation for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, ...
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Why Aquestive Therapeutics’ Seizure Treatment May Get Butted Out

Aquestive Therapeutics Inc. (NASDAQ: AQST) shares lost nearly a third on Monday after the firm received an update from the U.S. Food and Drug Administration (FDA). The long and short ...
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The Top Biopharma Events to Watch in 2020

Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to ...
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Why This Hairy Cell Leukemia Treatment Could Be Big in Europe

Innate Pharma S.A. (NASDAQ: IPHA) shares jumped on Thursday after the firm announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for Lumoxiti for adult patients ...
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Why This Refractory Angina Treatment Could Be a Big Hit

Neovasc Inc. (NASDAQ: NVCN) shares nearly doubled on Tuesday after the firm announced the submission of a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for ...
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Why This aPAP Treatment Is a Big Hit

Savara Inc. (NASDAQ: SVRA) shares more than doubled on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its autoimmune ...
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AstraZeneca’s FDA Nod Could Be Big

AstraZeneca PLC (NYSE: AZN) has announced that the U.S. Food and Drug Administration (FDA) has approved its companion diagnostic test that identifies patients with metastatic pancreatic cancer. Specifically, the approval ...
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Could This Breast Cancer Study Be the Next Big Thing?

Immunomedics Inc. (NASDAQ: IMMU) shares made a handy gain on Thursday after the company announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) ...
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Why This Cancer Study Is Crushing Spectrum Pharma

Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) shares were halved on Thursday after the firm provided an update on its midstage cancer study. The company also gave some updates on its late-stage ...
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Allergan Gets FDA Approval for Migraine Treatment

The U.S. Food and Drug Administration (FDA) on Thursday announced that it had approved ubrogepant tablets in dosages of 50 mg and 100 mg for the immediate treatment of migraine ...
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