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ICER Questions Diversity Action Plan Goal

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The Institute for Clinical and Economic Review asks FDA to reconsider the implications of its stated goal in a draft guidance on c...

FDA OKs Keytruda Pleural Mesothelioma Indication

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FDA approves an additional indication for Mercks Keytruda with chemotherapy to treat unresectable advanced or metastatic malignant...

Bill Introduced on Generic Drug Prompt Approvals

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Congresswoman Nanette Barragn (D-CA) reintroduces the Prompt Approval of Safe Generic Drugs Act, legislation that would remove hur...

FDA Review of Govorestat on Track: Company

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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.

Integrating Trials into Clinical Practice Guide

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Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biolo...

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Federal Register notice: FDA makes available a draft guidance entitled Considerations for Generating Clinical Evidence From Oncolo...