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FDA Articles
Shire made waves Tuesday morning following a key FDA approval of its eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients.
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Ampio Pharmaceuticals, Inc. (NYSEMKT: AMPE) is watching its shares get cut in half on Thursday after news of a failed late-stage trial. The company announced the results of its Ampion PIVOT clinical...
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Eli Lilly and Co. (NYSE: LLY) is watching its shares make a decent gain on Wednesday following a U.S. Food and Drug Administration (FDA) vote. The FDA Advisory Committee voted 12-11 that substantial...
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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 announced it...
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Shares of Fate Therapeutics saw a healthy gain early on Monday following a key U.S. Food and Drug Administration (FDA) approval.
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Whole Foods Market is under fire by federal regulators after an inspection of its food processing operations conducted back in February.
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Sarepta Therapeutics Inc. (NASDAQ: SRPT) shares saw a handy gain on Wednesday following an analyst upgrade from Janney Montgomery Scott.
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Theravance Biopharma has announced that the FDA approved its supplemental New Drug Application for Vibativ (telavancin) to expand the product's label.
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Several big FDA decisions should be coming up in the June quarter for the likes of AstraZeneca and Sarepta Therapeutics.
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A pharmaceutical company could face a threat to one of its products for a number of reasons, ranging from an improved formulation to a patent expiry and the opening of the floodgates for generic...
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Catalyst Pharmaceuticals saw its shares get halved just Tuesday morning alone, following a business update regarding its Lambert-Eaton myasthenic syndrome treatment.
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Although the markets have made their comeback, some stocks are still slowing that recovery and punishing their shareholders. Last week that included Netflix and Sarepta Therapeutics.
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TransEnterix has announced that the FDA notified it that its SurgiBot System does not meet the criteria for substantial equivalence based on the data and information submitted.
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BioMarin Pharmaceutical is ready to break above the $1 billion revenue barrier in 2016, a feat that marks a major hurdle for many biotech and emerging pharmaceutical companies.
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Shares of Clovis Oncology dropped after the FDA Oncologic Drugs Advisory Committee voted against its lung cancer drug.
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