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Leqvio Successfully Lowers LDL-C: Study

[ Price : $8.95]

Novartis says its Leqvio successfully lowered LDL cholesterol as a monotherapy in the Phase 3 V-MONO trial.

FDA Warns Companies on Unapproved CPAP Cleaners

[ Price : $8.95]

FDA warns three companies illegally marketing CPAP cleaning/sanitizing devices in the U.S.

Soleno Therapeutics NDA for Prader-Willi Drug

[ Price : $8.95]

FDA accepts for priority review a Soleno Therapeutics NDA for DCCR (diazoxide choline) for treating Prader-Willi syndrome (PWS) in...

SpringWorks Therapeutics NDA Accepted by FDA

[ Price : $8.95]

FDA accepts for priority review a SpringWorks Therapeutics NDA for mirdametinib, an investigational MEK inhibitor for treating ped...

Liveyon Founder Pleads Guilty

[ Price : $8.95]

Liveyon founder and CEO John Kosolcharoen pleads guilty to a felony charge of introducing an unapproved new stem cell product into...

Malfunction Reporting Program Guidance

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FDA publishes a guidance describing and clarifying several aspects of the Voluntary Malfunction Summary Reporting program.

Require More Breakthrough Postmarket Studies: Research

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Researchers call on FDA to require postmarketing studies for breakthrough therapy-designated drugs studied with surrogate endpoint...

Abbott Class 1 Recall of FreeStyle Libre Sensors

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Abbott Diabetes Care begins a Class 1 recall (device correction) of its FreeStyle Libre 3 sensors based on users reporting situati...

Global Calcium India Facility Hit with FDA-483

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An FDA inspection of a Global Calcium manufacturing facility in Hosur, India leads to a six-observation Form FDA-483 that cites si...

Patient Engagement Panel to Discuss Informed Consent

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Federal Register notice: FDA announces a 10/30 Patient Engagement Advisory Committee meeting that will discuss and make recommenda...