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Lillys Tirzepatide Curbs Progression to Diabetes

[ Price : $8.95]

Eli Lilly says data from its SURMOUNT-1 study showed that tirzepatide contributed to significant weight loss and delayed in progre...

Post Timely De Novo Summaries: Law Firm

[ Price : $8.95]

A Hyman, Phelps & McNamara medical device regulatory expert and attorney say FDA needs to improve the timeliness of its posting of...

ICU Medical Expands Class 1 Recall of Infusion Pumps

[ Price : $8.95]

ICU Medical expands a Class 1 recall of its Plum 360, Plum A+ and Plum A+3 Infusion Systems to update the use instructions due to ...

Transplant Drug Gets Orphan/Fast Track Status

[ Price : $8.95]

FDA grants ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients...

Pennsaid Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Horizon Therapeutics Pennsaid (diclofenac sodium) topical solution 2% was not withdra...

ANDA Product-Specific Meeting Request Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Product-Specific Guidance Meetings Between FDA and ANDA App...

J&J Combo Approved for Lung Cancer

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FDA approves a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of c...

FDA Clears SI-Bone Pelvic Fracture Implant

[ Price : $8.95]

FDA clears a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusi...

SoClean CPAP Disinfecting Device Authorized

[ Price : $8.95]

CDRH grants a de novo marketing authorization for SoCleans 3+ Bacterial Reduction Device, an over-the-counter product intended to ...

Enhertu Given Breakthrough Status in Breast Cancer

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FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for tre...