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FDA Approves New Epclusa Indication

[ Price : $8.95]

FDA summarizes Epclusa label changes to cover a new Covid indication.

FDA Use of Subjective Evidence Questioned

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Researchers from two law schools and a medical school urge FDA to accept and use more subjective evidence in considering treatment...

Endologix Ovation iX Correction Notice Class 1

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FDA says it considers an Endologix Ovation iX correction notice as a Class 1 recall.

Guide on Animal Drug Biomarkers/Surrogate Endpoints

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Federal Register notice: FDA makes available a draft guidance entitled Biomarkers and Surrogate Endpoints in Clinical Studies Supp...

Draft on Adaptive Trial Designs for Animal Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Adaptive and Other Innovative Designs for Effectiveness Stu...

FDA Approves Edwards Aortic Valved Conduit

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FDA approves an Edwards Lifesciences PMA for the Konect Resilia aortic valved conduit, a ready-to-implant device for bio-Bentall p...

Prostate Tissue Ablation Device Trial Guide

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Federal Register notice: FDA makes available a final guidance entitled Clinical Investigations for Prostate Tissue Ablation Device...

Guide on Medical Device eSubmissions

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Federal Register notice: FDA makes available a final guidance on medical devices submissions in an electronic format.

Generic Drug Price-Fix Case Targets Teva as Bellwether

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A Pennsylvania federal judge says a generic drug price-fixing case against Teva will move forward as a bellwether to explore claim...

Janssens Tremfya Okd for Active Psoriatic Arthritis

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FDA approves a Janssen supplemental BLA for tremfya (guselkumab) for adult patients with active psoriatic arthritis.