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Human Drugs

FDA Approves UroGen Bladder Cancer Therapy

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

Medical Devices

Viz.ai Subdural Hemorrhage Quantifier Cleared

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

Animal Drugs

Researchers Challenge FDA Lamictal Safety Warning

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

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FDA General

More FDA Operational Changes Coming: Makary

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

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Human Drugs

Sumitomo Gets Fast Track Status for Nuvisertib

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

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FDA General

CDC, NIH Staff Protest Trump Administration Chaos

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

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Human Drugs

Amish Origins Marketing Unapproved Drugs: FDA

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

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Human Drugs

FY 2024 Real-World Evidence Statistics Out

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

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Human Drugs

Bayesian Demo Project Explained

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

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Human Drugs

Government Drug Price Listening Sessions

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