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…
Read MoreFood and Drug Administration
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…
Read MoreFDA Approves Cellular Therapy for Advanced Melanoma
Approval provides early access to therapy while clinical trials continue. The U.S. Food and Drug Administration (FDA) recently approved Amtagvi (lifileucel) as the first cellular therapy for adults…
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FDA Finding Prompts Recall of Eye Ointment Products
The agency reported one of the products lacked the assurance of sterility. The Food and Drug Administration (FDA) issued an announcement this week that four types of eye…
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