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Takedas Entyvio OKd for Crohns Maintenance

[ Price : $8.95]

FDA approves Takedas Entyvio (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severe...

AdvaMed Seeks Clarification on Ethnicity Data in RWE

[ Price : $8.95]

The Advanced Medical Technology Association says FDAs draft guidance on diversity plans for clinical trials needs to address what ...

Rinvoq Shows Promise in Arteritis: AbbVie

[ Price : $8.95]

AbbVie reports positive top-line results from SELECT-GCA, a Phase 3, placebo-controlled study that showed the companys arthritis d...

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

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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

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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...