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  1. Horizon Therapeutics plc HZNP recently announced that the FDA has accepted the Biologics License Application (BLA) for its investigational medicine, teprotumumab, for the treatment of ...

  2. An unpublished notice was filed Wednesday by the FDA in the Federal Register indicating it will officially open comments on the issue on Thursday. Cannabis currently is in the category ...

  3. Food and Drug Administration (FDA)'s Food Safety Modernization Act, or FSMA.

  4. The Food and Drug Administration (FDA) is chastising vape giant Juul for claiming that its products were safer than cigarettes as well as the company's general marketing practices. The ...

  5. PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug.

  6. Novartis AG NVS announced that the FDA has granted a Breakthrough Therapy designation to its MET inhibitor capmatinib (INC280) for the first-line treatment of patients with metastatic ...

  7. Endo International plc ENDP announced that Novitium Pharma, LLC, a partner of its subsidiary Endo Ventures Limited, secured an approval from the FDA for a room temperature stable, AB-rated ...

  8. FDA: No Adcom Meeting For Intra-Cellular's Schizophrenia Drug

    Benzinga via Yahoo FinanceSep 10 15:33 PM

    Intra-Cellular Therapies Inc (NASDAQ: ITCI) shares were volatile Tuesday after the actively traded, small-cap biotech announced that the FDA has informed the company that it does not ...

  9. Juul’s Marketing of Device May Have Violated Law, FDA Says

    Bloomberg via Yahoo FinanceSep 09 15:59 PM

    Juul has pitched its sleek, USB-like vaping device as a way for adults to quit smoking -- though the FDA said that the company also targeted students. The reprimand could foreshadow a ...

  10. U.S. FDA warns Juul over its marketing practices

    Reuters via Yahoo FinanceSep 09 15:46 PM

    The FDA said it was concerned that Juul's representation of products may look like switching to its vaping device was a safer alternative to cigarettes.

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