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PTC Therapeutics Friedreichs Ataxia Drug Rejected

[ Price : $8.95]

FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the ...

Clinical Hold on BiomX Cystic Fibrosis Therapy

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FDA places a clinical hold on a BiomX Phase 2b trial of BX004, an investigational phage therapy for cystic fibrosis.

Viking Reports Mixed Data on Obesity Drug

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Viking Therapeutics reports mixed data from a Phase 2 study for its oral obesity drug VK2735, with patients losing up to 12.2% of ...

AI-DSF Change Control Plan Guidance

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FDA publishes a guidance with recommendations on the information to be in a predetermined change control plan in a marketing submi...

FDA Denies Ferring Reconsideration Petition

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FDA denies a Ferring Pharmaceuticals petition asking the agency to reconsider its earlier denial of a petition seeking restriction...

Test and Report Leachable Nitrosamines: FDA

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An FDA guidance asks manufacturers and applicants of drug products packed in infusion bags to collect and report data on nitrosami...

NeuroOnes Trigeminal Nerve Ablation Cleared

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FDA clears a NeuroOne Medical Technologies 510(k) to market its OneRF Trigeminal Nerve Ablation System for use in procedures to cr...

Cancer Radiopharm. Dosage Guide

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FDA posts a new draft guidance entitled Oncology Therapeutic Radiopharmaceuticals (RPTs): Dosage Optimization During Clinical Deve...

Stealth Refiles NDA for Barth Syndrome Drug

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Stealth BioTherapeutics resubmits its NDA for elamipretide for treating Barth syndrome.

Court Orders FDA to Reconsider Vanda sNDA

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An appeals court rules that FDA improperly rejected Vanda Pharmaceuticals request for a hearing on its supplemental NDA for sleep ...