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  1. District Court judge in Washington, D.C. issued a decision that upheld FDA's interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in ...

  2. Vaping Seizures? FDA Investigating 127 Reported Cases

    InvestorPlace via Yahoo FinanceAug 08 16:24 PM

    Food & Drug Administration (FDA) announced that it is investigating 127 cases of seizures and other negative neurological reactions that may be linked to vaping. This doesn’t confirm ...

  3. FDA approves first therapy for rare joint tumor

    PR Newswire via Yahoo FinanceAug 02 18:59 PM

    The tumor can significantly affect a patient's quality of life and cause severe disability," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting ...

  4. These new actions are part of the FDA's ongoing, aggressive effort to investigate and take action against illegally marketed tobacco products amid the epidemic of youth e-cigarette use ...

  5. When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act and complement additional important work the FDA is undertaking to advance ...

  6. It is the manufacturer's responsibility to submit complete and accurate information in marketing applications for evaluation by the FDA. If we become aware of a concern with data submitted ...

  7. (NASDAQ: EYEG) shares are trading higher after the company received FDA approval to initiate its follow-on pilot study for punctate epitheliopathies (PE). The study will use the Ocular ...

  8. Novartis AG (NYSE: NVS)'s Zolgensma, the first gene therapy approved for pediatric patients with spinal muscular dystrophy Type 1, has caught the FDA's attention due to a disclosure by ...

  9. Food & Drug Administration (FDA), amongst others, over its unreasonable and arbitrary Pre-Market Tobacco Application ("PMTA") process and the recently grossly accelerated PMTA filing ...

  10. The FDA said it is carefully assessing the situation. The FDA does not believe that the manipulation impacts the safety or testing surrounding the version of the drug, which treats ...

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