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FDA Review of Govorestat on Track: Company

[ Price : $8.95]

FDA tells Applied Therapeutics its govorestat is on track for the 11/28 PDUFA action date and will not need to go before an adviso...

Smiths Medical Recalls Bivona Tracheostomy Tubes

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Smiths Medical recalls (Class 1) several lots of its Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing...

Fasenra OKd for Rare Vasculitis

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FDA approves AstraZenecas Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis.

Positive Data Reported on Lung Cancer Therapy

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Merck and Daiichi Sankyo say their HERTHENA-Lung02 Phase 3 trial evaluating patritumab deruxtecan in certain patients with locally...

Advisory Panel to Weigh AI-Enabled Devices

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Federal Register notice: FDA announces an 11/20-21 Digital Health Advisory Committee meeting to discuss generative artificial inte...

Oncology Drug Multiregional Clinical Trial Guide

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncolo...

Transplant Viral Nucleic Acid Tests in Class 2

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Federal Register notice: FDA classifies quantitative viral nucleic acid tests for transplant patient management into Class 2 (spec...

Integrating RCTs into Routine Clinical Practice

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FDA publishes a guidance on integrating clinical trials into routine clinical practice.

Safety Alert on Zimmer Hip System

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FDA issues a safety alert about an increased risk of thigh bone fracture after surgery with the use of the Zimmer Biomet CPT Hip S...

Decentralized Clinical Trial Guidance

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FDA publishes a guidance on the conduct of clinical trials with decentralized elements.