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Human Drugs

Researcher May Solve Triple Negative Breast Cancer

Researchers say they have found a way to use a nano-bomb to potentially treat triple negative breast cancer.

Human Drugs

Biogen/Eisai Scrap Phase 3 Alzheimers Trials

Biogen and Eisai discontinue global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mil...

Medical Devices

GenePOC Strap A Assay Cleared

FDA clears a GenePOC 510(k) for the GenePOC Strep A assay for use on its revogene device.

Human Drugs

FDA Real-World Evidence Framework Explained

CDER Office of Medical Policy director Jacqueline Corrigan-Curray uses a Webinar to explain how the Center is approaching the collection and use of re...

Medical Devices

FDA OKs Impulse Dynamics Heart Device

FDA approves an Impulse Dynamics PMA for the Optimizer Smart system for treating certain patients with chronic, moderate-to-severe heart failure.

Human Drugs

Enzyvant Gains Rare Pediatric Disease/Fast Track Status

FDA grants Enzyvant rare pediatric disease and fast track designations for RVT-801, an investigational enzyme replacement therapy.

Human Drugs

Novo Nordisk Files 2 Semaglutide NDAs

Novo Nordisk files two NDAs for oral semaglutide, the first once-daily, glucagon-like, peptide-1 receptor agonist in a pill.

Human Drugs

Jazz Daytime Sleepiness Drug Approved

FDA approves a Jazz Pharmaceuticals NDA for Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associate...

Human Drugs

Moratorium on New, Reformulated Opioids Sought

A current and a retired FDA physician advisor say there should be a moratorium on agency approval of any new or reformulated opioids until FDA impleme...

Human Drugs

CDER Reorganization Finalized

CDER director Janet Woodcock says a Center reorganization involving four Offices has been approved.