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FDA Accepts NDA for Wilsons Disease

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FDA accepts for review an Orphalan NDA for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilsons Diseas...

Petition Wants 2 Cassava Simufilam Trials Halted

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Attorney Jordan Thomas asks FDA to halt clinical trials of Cassava Sciences simufilam until the agency thoroughly evaluates the sc...

Panel to Review Prader-Willi Syndrome NDA

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Federal Register notice: FDA announces an 11/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Levo Therapeutics...

FDA Orders New Warning on JAK Inhibitors

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FDA orders a drug class warning for Janus kinase inhibitors after reviewing a recent clinical trial that showed an increased risk ...

Ranitidine Products May Return to Market: FDA

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FDA says it may approve returning ranitidine-containing products to the market based on new CDER research into the carcinogen NDMA...

AnazaoHealth Compounding Unapproved Drugs: FDA

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FDA warns AnazaoHealth that it is compounding drugs that do not meet legal requirements and are considered to be misbranded unappr...

Astellas Pauses ASPIRO Trial

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Astellas pauses screening and dosing additional participants in its ASPIRO trial of an investigational gene therapy.

Woodcock Attempts to Quell CBER Dissent

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FDA acting commissioner Janet Woodcock weighs in on the announced departures of two senior CBER vaccine officials, pledging suppor...

Asensus Surgical Laparoscopy Device Enhancements Cleared

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FDA clears an Asensus Surgical 510(k) to expand the machine vision capabilities of its previously cleared Intelligent Surgical Uni...

Merck Gains Keytruda Full Approval in Bladder Cancer

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FDA converts Mercks accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line tre...