FDA Related News

Biologics

Interchangeable Product Development Strategy Outlined

FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.

Biologics

Ultragenyx Gains Approval for Resubmitted Gene Therapy

FDA approves Ultragenyx Pharmaceuticals Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome ...

FDA General

FDA Commissioner Nominee Overton Gets 9/24 Confirmation Hearing

The Senate HELP Committee sets a 9/24 confirmation hearing on the nomination of Heidi Overton to be the next FDA commissioner.

Human Drugs

Aquestive Therapeutics Refiles NDA for Anaphylm Sublingual Film

Aquestive Therapeutics resubmits its NDA for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis...

Human Drugs

Data Dont Show Sustained, Structurally Rising CR Rate: Report

FDA publishes a longitudinal study of CDER first-cycle NDA and BLA review decisions that it says indicates there has not been a significant increase i...

Medical Devices

Guidance Outlines eSTAR Submissions for PMAs

FDA posts a draft guidance, Electronic Submission Template for Premarket Approval Applications (PMAs), outlining an eSTAR electronic submission templa...

Human Drugs

FDA Finalizes Guide on Use of Buffy Coat Blood Processing

FDA finalizes a guidance intended to facilitate development of blood collection, processing and storage systems that would allow U.S. blood establishm...

Prepare for Enhanced FDA/SEC Oversight: Sidley

Sidley attorneys say regulated companies should expect heightened federal government oversight due to a recent information-sharing memorandum of under...

FDA General

Senate Looks to Rush Overtons FDA Head Nomination: Report

The Senate HELP Committee prepares to hold a confirmation hearing for FDA commissioner nominee Heidi Overton as soon as next week.

Human Drugs

FDA Adds Kybella Warning Over Serious Risks From Off-Label Injections

FDA approves new safety warnings for AbbVies Kybella (deoxycholic acid) after identifying serious adverse events when the fat-dissolving drug was inje...