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FDA Approves UroGen Bladder Cancer Therapy

[ Price : $8.95]

FDA approves a UroGen Pharma NDA for Zusduri (mitomycin intravesical solution) for adult patients with recurrent low-grade interme...

Viz.ai Subdural Hemorrhage Quantifier Cleared

[ Price : $8.95]

FDA clears a Viz.ai 510(k) for the Viz Subdural Plus, which the company describes as the first and only comprehensive solution for...

Researchers Challenge FDA Lamictal Safety Warning

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Rutgers University researchers say they have determined that the GlaxoSmithKline anti-seizure drug Lamictal is safe for adults wit...

More FDA Operational Changes Coming: Makary

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Saying that operational consolidations are coming in support services, FDA commissioner Martin Makary asks the staff to view chang...

Sumitomo Gets Fast Track Status for Nuvisertib

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FDA grants Sumitomo Pharma America a fast track designation for nuvisertib (TP-3654) and its use in treating patients with interme...

CDC, NIH Staff Protest Trump Administration Chaos

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Current and former CDC employees rally outside the agencys Atlanta headquarters yesterday over Trump Administration-inspired chaos...

Amish Origins Marketing Unapproved Drugs: FDA

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FDA warns Worland, WY-based Amish Origins Management about CGMP violations in its manufacturing of unapproved and misbranded drug ...

FY 2024 Real-World Evidence Statistics Out

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FDA publishes statistics on real-world evidence submissions to CBER and CDER in FY 2024 compared to the previous year.

Bayesian Demo Project Explained

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FDA posts an online notice explaining CDERs Bayesian Statistical Analysis demonstration project.

Government Drug Price Listening Sessions

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The Federal Trade Commission and Justice Department announce three live-streamed listening sessions on aspects of the effort to cu...