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FDA General

FDA Reform Requires a Whole-of-System Strategy: Editorial

A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only way to successfully...

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FDA General

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adopti...

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FDA General

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...

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FDA General

Opinion Piece Praises Diamantas' Vision for FDA Modernization

A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emphasizing innovation,...

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Medical Devices

FDA Issues Early Alert on Baxter IV Administration Sets

FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could ...

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Human Drugs

China Surpasses U.S. in Novel Cancer Drug Approvals Since 2023: Analysis

China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs beginning in 2023, accor...

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Biologics

Dyne Therapeutics BLA for Duchenne Muscular Dystrophy

FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy amenable ...

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Human Drugs

Nevada Man Pleads Guilty to Importing and Selling Misbranded Drugs

A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from India.

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Human Drugs

Study Finds Compounded GLP-1 Market Remains Strong Despite FDA Crackdown

A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of e...

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Human Drugs

FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...