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FDA Articles
Aquestive Therapeutics shares jumped on Monday after the firm announced that its treatment of amyotrophic lateral sclerosis (ALS), Exservan, received early-action approval from the U.S. Food and Drug...
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Kiniksa Pharma shares jumped on Wednesday after the firm announced that the FDA granted Breakthrough Therapy designation for rilonacept for the treatment of recurrent pericarditis.
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Solid Bio shares were absolutely crushed on Tuesday after the firm announced that the FDA has placed its Ignite DMD Phase 1/2 study of SGT-001 on hold.
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Lipocine shares absolutely plummeted on Monday after the firm announced that it received a Complete Response Letter from the FDA regarding its New Drug Application for Tlando.
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Redhill Bio shares jumped early on Monday after the firm announced that the FDA approved Talicia for the treatment of Helicobacter pylori infection in adults.
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Biogen and Alkermes have announced that the FDA approved Vumerity for the treatment of relapsing forms of multiple sclerosis.
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Melinta shares dropped on Friday even though the firm announced that the FDA has approved Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia.
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Eton Pharma shares jumped on Tuesday after the firm announced that the FDA has approved Biorphen for treatment of hypotension.
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Flexion Therapeutics has announced that the FDA needs additional time to complete the review of its osteoarthritis knee pain treatment.
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DBV Technologies shares dipped on Monday after the firm announced an update from the FDA. Although it was a positive update for the company, this appears to be a case of “sell the news.”
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The FDA is coming down hard after the disclosure that Zantac and other generic ranitidine drugs could contain impurities and carcinogens.
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Merck has just announced that the FDA has accepted a couple new drug applications for review, including for a treatment for Clostridium difficile infections in children.
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Achillion Pharma shares jumped on Wednesday after the firm announced that the FDA has granted Breakthrough Therapy designation for danicopan (ACH-4471).
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Avadel Pharma shares jumped on Monday morning after the firm announced that the FDA has agreed to the company’s proposed amendments to a statistical analysis plan and protocol.
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NewLink Genetics shares jumped on Wednesday after the firm announced that the FDA has accepted Merck’s Biologics License Application and granted priority review for the investigational Ebola...
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