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Medical Devices

FDA OKs Vagus Nerve Stimulation for Stroke Patients

FDA approves a MicroTransponder PMA for the Vivistim Paired VNS System, a vagus nerve stimulation device intended to treat moderate to severe upper ex...

Federal Register

Nonprescription Drugs Panel Renewed for 2 Years

Federal Register notice: FDA renews its Nonprescription Drugs Advisory Committee for an additional two years.

Federal Register

Circulatory System Panel Meeting on Endovascular Grafts

Federal Register notice: FDA announces an 11/2-3 Medical Devices Advisory Committee Circulatory System Devices Panel meeting to discuss endovascular g...

Federal Register

Panel to Vote on Integra LifeSciences Breast Reconstruction

Federal Register notice: FDA announces a 10/20 advisory committee meeting to vote on a Integra LifeSciences PMA for the SurgiMend PRS Acellular Bovine...

Human Drugs

Cumberland Recruiting MS Study Participants

Cumberland Pharmaceuticals recruits patients for a Duchenne muscular dystrophy cardiomyopathy trial of ifetroban funded by FDA.

FDA General

Draft Guide on PD-1, PD-L1 Alternative Dosing

Federal Register notice: FDA makes available a draft guidance entitled Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Pr...

Human Drugs

FDA Approves Expanded Age for Ironwoods Linzess

FDA approves a revised label for Ironwoods Linzess expanding the potential for off-label use in children under age 18.

Medical Devices

Court Tosses Boston Scientific Whistleblower Case

Three Sidley Austin attorneys describe a Minnesota federal court decision rejecting a whistleblowers claims that Boston Scientific fraudulently induce...

FDA OKs Expanded Tibsovo Indication Plus Diagnostic Test

FDA approves an expanded indication for Serviers Tibsovo plus a companion diagnostic test to identify patients for the new indication.

Human Drugs

Takeda Illegally Extended Actos Patents: Court

The 2nd Circuit Appeals Court says antitrust suits alleging that Takeda illegally delayed generic entry of its diabetes drug Actos can continue.