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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Pennsaid Not Withdrawn Due to Safety/Efficacy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

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

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...

Hold Lifted on Lung/Breast Cancer ADC Drug

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FDA lifts a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a H...

SoClean CPAP Disinfecting Device Authorized

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

Guide on ANDA Meeting Requests

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FDA posts a final guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.

Vaccines Panel to Discuss Pertussis Study Model

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Federal Register notice: FDA announces a 9/20 Vaccines and Related Biological Products Advisory Committee to discuss controlled hu...