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BioMarin Halts Dosing in Some Voxzogo Mid-Stage Trials

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BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) aft...

Integra Neurosurgical Kits Recalled Over Corrosion Risk

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Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component use...

Quality Control, Microbial Risks Flagged at API Manufacturer

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FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multip...

Praise for FDA Bayesian Methodology Draft Guidance

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Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the ...

FDA Draft Guidance on Responses to FDA-483s Explained

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Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers re...

FDA Rejects Aldeyras Dry Eye Drug Reproxalap

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FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company fai...

FDA Extends Review of Lantheus PET Imaging Agent

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FDA extends by three months its review of a Lantheus Holdings NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocri...

Senators Demand HHS Reverse Autism-Related Web Site Changes

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A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered...

FDA Flags Sterility, Contamination Control Issues at India Plant

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FDA inspectors cite multiple manufacturing and quality control deficiencies at a Gland Chemicals Private Limited in Chennai, India...

FDA Updates Internal Procedures for Handling Supplements

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FDA updates an internal policy document outlining how CBER staff process supplements to approved drug and biologic applications.