Public health advocates question the delay and civil rights groups are concerned with minority health. The Department of Health and Human Services (HHS) recently moved back the implementation…
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Federal Court Places Injunction Over Sleep Therapy Device Safety Concern
Consent decree mandates remediation plan following worldwide recall, FDA oversight ensures patient safety and compliance The District Court for the Western District of Pennsylvania issued a permanent injunction…
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Biotech CEO Sentenced for Obstructing Investigation of Fake COVID-19 Tests
Keith Berman defrauded medical device investors and lied to the FDA. The CEO of a fraudulent California biotechnology company was sentenced to seven years of prison on Friday…
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FDA Approves Duchenne Muscular Dystrophy Treatment for Children
Duvyzat receives approval under fast-track designation. The U.S. Food and Drug Administration (FDA) has approved Duvyzat (givinostat) as an oral medication for the treatment of Duchenne Muscular Dystrophy…
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FDA Warns Against Over-the-Counter Pain Relief Products for Cosmetic Procedures
Six companies receive warning letters as the FDA addresses unsafe topical analgesics and urges consumer vigilance. The U.S. Food and Drug Administration (FDA) has cautioned against using specific…
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FDA Approves Medication for Liver Scarring
The medication was fast-tracked through the agency’s accelerated approval pathway. The U.S. Food and Drug Administration (FDA) has authorized Rezdiffra (resmetirom) for adults experiencing noncirrhotic non-alcoholic steatohepatitis (NASH),…
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Supreme Court Hears Medication Abortion Case
Mifepristone is a prescription drug used in medication abortions that can sent via the mail. The Supreme Court heard initial arguments for the restriction of mifepristone, a prescription…
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Prosecutors Investigate Meta For Possible Involvement in Illegal Drug Sales
FDA assists in the review of records from the social media company. Federal prosecutors have begun a probe into Facebook’s parent company, Meta, to determine whether its social…
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FDA Approves Wegovy for Cardiovascular Risk Reduction
The injection becomes the first weight loss medication to address life-threatening cardiovascular events. The Food and Drug Administration has expanded the approved use of Wegovy (semaglutide) injection, making…
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House Passes Package of Six Appropriations Bills
The $460 billion so-called “minibus” averts a partial government shutdown. The House of Representatives passed a more than one-thousand-page, $460 billion package to fund the federal government, averting…
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