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Human Drugs

FDA Seeks Computational Algorithms for Adverse Events

FDA seeks outside groups or individual data scientists to develop computational algorithms to identify adverse event anomalies in open FDA adverse eve...

Human Drugs

Epizymes Tazverik Gets Accelerated Approval

FDA grants accelerated approval for Epizymes Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or loca...

Medical Devices

Abbott Expanded Indication for Brain Stimulator

FDA approves an expanded indication for Abbotts Infinity Deep Brain Stimulation system to include targeting of an area of the brain called the interna...

Human Drugs

Tecentriq Study in Urothelial Cancer Misses Endpoint

A Genentech Phase 3 study of Tecentriq (atezolizumab) in people with muscle-invasive bladder (urothelial) cancer misses its primary endpoint of diseas...

Medical Devices

King Vision Video Laryngoscopes Recalled

King Systems recalls 171 units of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image.

Human Drugs

2 Drug Interaction Guidances Out

FDA publishes two guidances describing a systematic system for evaluating drug-drug interactions and communicating about them in labeling.

Human Drugs

AbbVie Seeking New Orilissa Indication

The Philadelphia Inquirer reports that FDA is expected to rule later this year on a proposed new indication to treat uterine fibroids in premenopausal...

FDA General

Dietary Supplements Recalled Over GMP Inspection

ABH Nature's, ABH Pharma and Stocknutra.com recalls its dietary supplement products manufactured and sold between 1/2013 to 11/2019.

Medical Devices

Baze At-home Blood Nutrient Test Cleared

FDA clears a Baze 510(k) for its at-home blood collection process and its use to assess blood nutrient status.

Medical Devices

Medtronic Gets OK for PulseSelect Ablation Trial

FDA gives Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of its PulseSelect Pulsed Field Ablatio...