FDA

Eton Pharma Wins Big With FDA Hypotension Treatment Approval

Posted: October 22, 2019 at 12:05 pm

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

Posted: October 14, 2019 at 10:00 am

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

Posted: October 7, 2019 at 9:45 am

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

Posted: October 4, 2019 at 12:30 pm

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?

Posted: October 4, 2019 at 10:10 am

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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FDA Accepts for Review the Newest Treatment for C Diff

Posted: October 2, 2019 at 10:30 am

Merck & Co. Inc. (NYSE: MRK) has just announced that the U.S. Food and Drug Administration (FDA) accepted a couple New Drug Applications (NDAs) for review. Specifically, the FDA accepted ...
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Achillion Pharma Wins Big With FDA Breakthrough

Posted: September 25, 2019 at 11:40 am

Achillion Pharmaceuticals Inc. (NASDAQ: ACHN) has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for danicopan (ACH-4471) in combination with a C5 monoclonal antibody ...
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Why This Late-Stage Narcolepsy Study Is Way Ahead of Schedule

Posted: September 23, 2019 at 10:00 am

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) shares jumped on Monday morning after the firm announced that the U.S. Food and Drug Administration (FDA) has agreed to the company’s proposed amendments to ...
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Will This Ebola Vaccine Be the Next Big Thing?

Posted: September 18, 2019 at 9:55 am

NewLink Genetics Corp. (NASDAQ: NLNK) shares jumped on Wednesday after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted Merck & Co.’s (NYSE: MRK) Biologics License ...
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Good News, Bad News in the War on Peanut Allergy

Posted: September 16, 2019 at 10:15 am

Aimmune Therapeutics Inc. (NASDAQ: AIMT) shares dipped on Monday after the Allergenic Products Advisory Committee (APAC) convened by the U.S. Food and Drug Administration (FDA) voted to support the use ...
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7 Biotechs With Catalysts in the Next Month

Posted: September 14, 2019 at 7:10 am

If there is one area that can generate riches for speculative investors, it would have to be biotech and emerging pharmaceuticals. After all, how many companies can go from nothing ...
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FDA Gets Off the Pot for IBS Treatment Approval

Posted: September 13, 2019 at 9:45 am

Ardelyx Inc. (NASDAQ: ARDX) shares dropped sharply on Friday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved its treatment of irritable bowel syndrome with ...
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Great News for Patients With Dangerously Low Blood Sugar

Posted: September 10, 2019 at 12:45 pm

Xeris Pharmaceuticals Inc. (NASDAQ: XERS) shares were halted briefly on Tuesday after the firm announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) for ...
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Is the FDA Canceling This Schizophrenia Treatment?

Posted: September 10, 2019 at 11:59 am

Intra-Cellular Therapies Inc. (NASDAQ: ITCI) shares dipped on Tuesday after the firm gave an update from the U.S. Food and Drug Administration (FDA). Essentially, the FDA informed Intra-Cellular that it ...
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Why This New Dementia Study Is a Huge Hit

Posted: September 9, 2019 at 9:40 am

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) shares rose sharply early Monday after the firm announced that its late-stage dementia study met its primary endpoint. Specifically, the results come from Acadia’s Phase ...
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