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Fujifilm Diosynth Cited Over NC Plants Microbial Contamination Controls

[ Price : $8.95]

FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Resea...

Camurus NDA Resubmission for Acromegaly Therapy Accepted by FDA

[ Price : $8.95]

FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.

Class I Recall of Bolton Medicals Relay Pro Thoracic Stent Graft System

[ Price : $8.95]

Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in seriou...

FDA Cites Charles River Endosafe Lab Over Quality System Deficiencies

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

Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

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A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated...

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 ...