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Human Drugs

FFujifilm Diosynth Cited Over NC Plants Microbial Contamination Controls

FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, N...

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Human Drugs

Alvotech EF FDA-483 Released

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

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Medical Devices

Court Backs FDA, Medtronic in Stimulator Suits

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

Human Drugs

CDER Planning 85 New, Revised Guidances

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

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Human Drugs

FDA OKs Merck's Oral PCSK9 Inhibitor for Lowering Cholesterol

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

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FDA General

Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes

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

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Human Drugs

13 Observations in Zhejiang Hushai Inspection

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

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Human Drugs

Active Drug Shortages Still Trending Up

The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trending up for the third q...

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Human Drugs

FDA Reevaluating Makarys Journal Articles, Podium Policies: DeGette

Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's tenure including art...

Medical Devices

Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA

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