FDA Press Releases RSS Feed

  • Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020

    Coronavirus (COVID-19) Update: Daily Roundup June 3, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

    Coronavirus (COVID-19) Update: Daily Roundup June 2, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer

    Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer

    FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer

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  • Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020

    Coronavirus (COVID-19) Update: Daily Roundup June 1, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Federal judge enters order of permanent injunction against New York company for distributing unapproved drugs

    Federal judge enters order of permanent injunction against New York company for distributing unapproved drugs

    Federal judge enters order of permanent injunction against New York company for distributing unapproved drugs

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  • Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

    Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

    FDA taking steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

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  • FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

    FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

    FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

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  • FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products

    FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products

    FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products

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  • Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease

    FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease

    FDA approved Tauvid for IV injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. Tauvid is a radioactive diagnostic...

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  • Coronavirus (COVID-19) Update: Daily Roundup

    Coronavirus (COVID-19) Update: Daily Roundup

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

    Coronavirus (COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

    FDA new step to support the evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are needed to ensure the quality of the tests, validation of...

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  • FDA Approves Only Drug in U.S. to Treat Severe Malaria

    FDA Approves Only Drug in U.S. to Treat Severe Malaria

    FDA has approved artesunate for injection to treat severe malaria in adult and pediatric patients.

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  • FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

    FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

    FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

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  • Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 22, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020

    Coronavirus (COVID-19) Update: Daily Roundup

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  • Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

    Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

    The FDA has posted a list of antibody tests that are no longer being offered under the March 16, 2020 Policy, which is sometimes called the “notification list.”

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