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Federal Register

Panel to Review ProSense Cryoablation De Novo Request

Federal Register notice: FDA announces an 11/7 advisory committee meeting to review an IceCure Medical de novo request for its ProSense Cryoablation S...

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Human Drugs

FDA Veozah Liver Injury Warning

FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.

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Human Drugs

Recommendations on Rare Disease Collaboration

A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.

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Human Drugs

FDA Publishes 8th Revision of Electronic Format Guide

FDA publishes the eighth revision of a guidance on providing regulatory submissions for certain drug products in electronic format.

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Medical Devices

Apple AirPods Hearing Software Authorized

FDA authorizes Apples Hearing Aid Feature software to use with compatible AirPods Pro headphones to operate as an over-the-counter hearing aid for mil...

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Biologics

Tremfya Secures Approval for Ulcerative Colitis

FDA approves Johnson & Johnsons Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis.

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Biologics

Gilead Positive on Twice-Yearly HIV Drug Data

Gilead Sciences says data from a second pivotal Phase 3 clinical trial investigating its twice-yearly injectable lenacapavir show that it reduced HIV ...

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Biologics

GSK Moves mRNA Flu Vaccine to Phase 3

GSK moves its mRNA seasonal influenza vaccine program into Phase 3 after reporting favorable Phase 2 data.

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Human Drugs

CDER Quantitative Medicine CoE Explained

CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.

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Human Drugs

GDUFA ANDA Amendment Submissions

FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.