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NEWSROOM CLOSED FOR THE HOLIDAYS

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FDA Webview closes its newsroom for the end-of-year Holiday Season, reopening Monday, Jan 5, 2026.

Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

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House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to te...

Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

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Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the ...

Medical Device RWE Guidance

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FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evi...

Merck Cholesterol, Cancer Drugs Added to Voucher Program

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FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's Nati...

FDA Warns Catalent Indiana for CGMP Lapses

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FDA issues a Warning Letter to Catalents Bloomington, IN, drug manufacturing plant, citing significant manufacturing violations af...

Change Premarin Prescribing Info to Include Equilin: Petition

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Diamond Research Foundation founder Beth Rosenshein petitions FDA to update Premarin labeling with information on the estrogen hor...

FDA Agentic AI Deployment Raises Concerns

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Two Mintz attorneys urge stakeholders to monitor FDA communications involving compliance and review carefully, looking for issues ...

GSK Long-Acting Biologic Approved for Asthma

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FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.

FDA Easing Drug Approval Standards: Column

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A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.