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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 ...

13 Observations in Zhejiang Hushai Inspection

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FDA releases the form FDA-483 with 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.

Active Drug Shortages Still Trending Up

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The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trendin...

FDA Reevaluating Makarys Journal Articles, Podium Policies: DeGette

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Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's t...

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...