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CDER Head Targets Surrogate Endpoints, Lupus Drug

[ Price : $8.95]

In an unprecedented LinkedIn post, CDER director George Tidmarsh questions the use of surrogate endpoints and publicly attacks Aur...

Quantitative Medicine CoE Progress Update

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The CDER Quantitative Medicine Center of Excellence issues a report on goals and accomplishments in the first 16 months of its exi...

Sharp Reductions in FDA Operations Under Shutdown: HHS

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An HHS contingency plan says FDA would experience sharp reductions in operations if Congress fails to reach a deal to fund the gov...

New Guidance on Adaptive Clinical Trial Designs

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FDA posts an International Council for Harmonization draft guideline entitled E20 Adaptive Designs for Clinical Trials that provid...

CDRH Expands Recall of BD Alaris Pump Infusion Sets

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FDA issues an updated alert about an ongoing Class 1 recall of certain BD Alaris Pump Module infusion sets due to device performan...

FDA Protected From Firings During Shutdown: Makary

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FDA commissioner Marty Makary tells agency employees that they are protected from planned mass workforce firings if a government s...

Draft Guide on Disseminated Valley Fever Treatments

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FDA posts a draft guidance to help drugmakers design clinical trials for treatments targeting disseminated coccidioidomycosis, als...

Larimar Reports Positive Data for Nomlabofusp

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Larimar Therapeutics reports encouraging long-term data from its open-label study of nomlabofusp, an investigational therapy for F...

Novo Nordisk Resubmits BLA for Once-Weekly Insulin

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Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.

FDA Tells IO Biotech to Delay Cancer Vaccine Filing

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FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed P...