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AbbVie Files NDA for Parkinsons Drug Tavapadon

[ Price : $8.95]

AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.

Eyeglass Lenses OK'd for Pediatric Nearsightedness

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FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision a...

FDA Approves New Drug for Acromegaly

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FDA approves a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response t...

FDA Rebukes Novartis Over Misleading TV Ad

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FDA sends Novartis Pharmaceuticals an untitled letter citing the companys allegedly false or misleading direct-to-consumer televis...

Kennedy, Makary Pledge Mifepristone Review

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HHS secretary Robert F. Kennedy, Jr., says FDA is reviewing safety evidence relating to the medication abortion drug mifepristone.

FDA Ends Caprelsa REMS

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FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Cap...

Capricor Gets FDA OK on Duchenne BLA Refiling

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Capricor Therapeutics reaches agreement with FDA on the design and role of its HOPE-3 trial as it works to resubmit its BLA for De...

Hansa Biopharmas Imlifidase Hits Primary Endpoint

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Hansa Biopharma says imlifidase met the primary endpoint in a pivotal Phase 3 study in kidney transplant patients.

FDA NextGen Submission Portal Guide

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FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.

Public Confidence in FDA, Others Dropping: Survey

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The latest University of Pennsylvania Annenberg Public Policy Center survey documents a significant drop since last fall in the pe...