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Hold Lifted on Fabry Cardiomyopathy Therapy

[ Price : $8.95]

FDA lifts a clinical hold against 4D Molecular Therapeutics 4D-310 therapy being studied for treating Fabry disease cardiomyopathy...

Panel to Mull Clozapine REMS Potential Changes

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Federal Register notice: FDA announces an 11/19 advisory committee meeting to discuss potential changes to the clozapine risk eval...

4 Observations on Imprimis FDA-483

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FDA releases the form FDA-483 with four observations from an inspection at the Ledgewood, NJ-based Imprimis NJOF outsourcing facil...

Stakeholder Comments on FDA BIMO Guidance

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Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes...

Oncologic Drug Dosage Guidance

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FDA publishes a guidance on optimizing dosage for oncologic drug and biologic therapies.

Amneal Gets Approval for Parkinsons Drug

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FDA approves an Amneal Pharmaceuticals NDA for Crexont (carbidopa and levodopa) extended-release capsules for treating Parkinsons ...

Cipro 100mg Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn fro...

Drug Experiential Learning Site Visits for FY 2025

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Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit...

Accelerated Approval for Novartis Fabhalta

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FDA gives accelerated approval to Novartis Fabhalta for reducing proteinuria in primary IgA nephropathy.

Huxley Gains Clearance for At-Home Apnea Test

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FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.