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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...

BCG Treatment Development Guidance

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FDA publishes a draft guidance on developing drug and biological treatments for a specific bladder cancer.

FDA OKs Cutaneous T-cell Lymphoma Therapy

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FDA approves a Citius Pharmaceuticals BLA for Lymphir (denileukin diftitox-cxdl) for treating relapsed or refractory cutaneous T-c...

Purdues Opioid-Reversing Injector Approved

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FDA approves a Purdue Pharma NDA for Zurnai, a nalmefene hydrochloride auto-injector for the emergency treatment of known or suspe...

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Four stakeholders give FDA general and specific recommendations on a draft guidance on bioresearch monitoring inspection processes...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Cipro 100mg Withdrawn Due to Safety/Efficacy: FDA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Federal Register notice: FDA determines that Bayers Cipro (ciprofloxacin HCl) tablet, equivalent to 100 mg base, was withdrawn fro...