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Alvotech EF FDA-483 Released

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FDA releases the form FDA-483 with five observations from an inspection at Icelands Alvotech EF.

Court Backs FDA, Medtronic in Stimulator Suits

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MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys ...

CDER Planning 85 New, Revised Guidances

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FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

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FDA approves Merck's Lipfendra (enlicitide) 20 mg tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cho...

Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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Kalshi launches a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and ...

Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

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FDA warns Irvine, CA-based Nihon Kohden Digital Health Solutions that it is marketing an adulterated and misbranded unapproved med...

Hearing Highlights Concerns Over Biomedical Innovation Growing in China

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Witnesses at a House Energy and Commerce Health Subcommittee hearing urge lawmakers to modernize the nation's clinical trial syste...

House Hearing Previews Debate Over FDA Modernization, User Fees

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House Energy and Commerce Health Subcommittee leaders reveal differing views over whether the Trump administration's policies are ...

A New Era of Innovation for FDA Public Health Pillars

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FDA acting commissioner Kyle Diamantas positions the agencys four public health pillars as a means to fulfill its enduring mission...

VAI Close Out for HLB Inspection

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A Cancer Network post says FDA issued a voluntary action indicated close-out letter to HLB following a CGMP inspection at a facili...