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Data Show Long-Term Shingrix Efficacy: GSK

[ Price : $8.95]

GlaxoSmithKline says a follow-up trial of its Shingrix found 80% effectiveness in adults over age 50 up to 11 years after vaccinat...

Philips Respironics Recalls Trilogy Evo Ventilators

[ Price : $8.95]

Philips Respironics recalls its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the devices potential ...

FDA Approves Lumisight to Help Find Cancer

[ Price : $8.95]

FDA approves Lumicells Lumisight to assist in the detection of cancerous tissue in breast cancer patients undergoing a lumpectomy....

Priority Review Voucher to Orchard Therapeutics

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval...

Info Collection on Drug Expedited Programs

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Expedited Programs for Serious Conditions ...

New PMI Form Explained

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CDER Office of Medical Policy regulatory counsel Christopher Diamant explains why the new Patient Medication Information form was ...

SCOTUS Wont Hear False Labeling Case

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Two Polsinelli attorneys say the Supreme Courts refusal to hear an appeal in a labeling case helps manufacturers argue for preempt...

Woodcock Plays Advisory Role at Patient Nonprofit

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Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advis...

PhRMA Changes for Data Committee Guide

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PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.

Alecensa OKd for ALK-Positive Lung Cancer

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FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplasti...