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AstraZenecas Breztri Approved for COPD

[ Price : $8.95]

FDA approves an AstraZeneca NDA for Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatme...

MyoKardia Gets Breakthrough Status for Mavacamten

[ Price : $8.95]

FDA grants MyoKardia a breakthrough therapy designation for mavacamten, an oral, allosteric modulator of cardiac myosin for treati...

Right to Try Act Annual Summaries

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Federal Register notice: FDA proposes to establish requirements for the deadline and annual summary contents for sponsors and manu...

Info Collection Non-Clinical Good Lab Practices

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Federal Register notice: FDA seeks comments on an information collection extension for Good Laboratory Practice (GLP) for Non-Clin...

EUA Revoked After 510(k) Cleared on Zika Assay

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Federal Register notice: FDA revokes the Emergency Use Authorization issued to Chembio Diagnostic Systems for the DPP Zika IgM Ass...

Kite Therapy Approved for Mantle Cell Lymphoma

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FDA grants Kite accelerated approval for Tecartus (brexucabtagene autoleucel) for treating adult patients with relapsed or refract...

Surgical Insufflator/Smoke Evacuator Cleared

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FDA clears a Palliare 510(k) for its EVA15 insufflator and smoke evacuation system.

Taro Pays $205 Million in Generic Price Fixing Settlement

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Taro Pharmaceuticals agrees to pay $205 million in criminal fines to resolve charges of conspiring to fix prices for generic drugs...

Info Collection on ICH Good Clinical Practice Guide

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Federal Register notice: FDA sends to OMB an information collection extension for an International Council for Harmonization good ...

Pediatric Advisory Panel to Discuss Safety Reviews

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Federal Register notice: FDA announces a 9/15 Pediatric Advisory Committee meeting to discuss pediatric-focused safety reviews.