FDA

Why This Seizure Treatment Could Be the Next Big Thing

Aquestive Therapeutics Inc. (NASDAQ: AQST) shares jumped early on Monday after the firm announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food ...
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Major Biopharma Catalysts on the December FDA Calendar

Companies in the biotech and pharmaceutical industries are subject to a sizable amount of risk with regards to their drug candidates passing clinical trials and gaining regulatory approval. But with ...
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Why This Newly FDA Approved Sickle Cell Treatment Will Be Huge

Global Blood Therapeutics, Inc. (NASDAQ: GBT) shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Oxbryta (voxelotor) tablets ...
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A Big Step Forward For the Treatment of ALS

Aquestive Therapeutics, Inc. (NASDAQ: AQST) 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 ...
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Why This FDA Breakthrough Is a Big Deal for Recurrent Pericarditis Patients

Kiniksa Pharmaceuticals Ltd. (NASDAQ: KNSA) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for rilonacept for the treatment ...
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Is This DMD Study Sunk After FDA Update?

Solid Biosciences Inc. (NASDAQ: SLDB) shares were absolutely crushed on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has placed its Ignite DMD Phase 1/2 ...
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Is This FDA Update the Death of Lipocine?

Lipocine Inc. (NASDAQ: LPCN) shares absolutely plummeted on Monday after the firm announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding ...
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Meet the Newest FDA Approval in the Fight Against Non-Cardia Gastric Cancer

RedHill Biopharma Ltd. (NASDAQ: RDHL) shares jumped early on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) approved Talicia for the treatment of Helicobacter pylori ...
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Multiple Sclerosis Treatment Wins Big FDA Approval

Biogen Inc. (NASDAQ: BIIB) and Alkermes PLC (NASDAQ: ALKS) announced an update from the U.S. Food and Drug Administration on Wednesday morning. The FDA approved Vumerity for the treatment of ...
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It’s Not the FDA Holding Back This New Pneumonia Treatment

Melinta Therapeutics Inc. (NASDAQ: MLNT) has announced that the U.S. Food and Drug Administration (FDA) has approved Baxdela (delafloxacin) for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) ...
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Eton Pharma Wins Big With FDA Hypotension Treatment Approval

Eton Pharmaceuticals Inc. (NASDAQ: ETON) shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved Biorphen. Biorphen is the first and only ...
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New Osteoarthritis Treatment Has to Wait Even Longer for FDA Approval

Flexion Therapeutics Inc. (NASDAQ: FLXN) has announced that the U.S. Food and Drug Administration (FDA) informed the company that it needs additional time to complete the review of the supplemental ...
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Major Step Forward in Peanut Allergy Treatment

DBV Technologies S.A. (NASDAQ: DBVT) shares dipped early Monday after the firm announced an update from the U.S. Food and Drug Administration (FDA). Although it was a positive update for ...
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America’s Unsafe Medical Products

The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the final two weeks of September, six related to product recalls and one safety communication related to ...
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Is the FDA Going Too Soft on Zantac?

The U.S. Food and Drug Administration (FDA) is coming down hard after the disclosure that Zantac and other generic ranitidine drugs could contain impurities and carcinogens. Instead of just a ...
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