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Federal Register

EUA Revoked on Veklury After sNDA Approved

Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treating Covid-19 because ...

Human Drugs

Avadel Sues FDA Over Lumryz NDA Delay

Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.

Biologics

Develop Regulatory Framework for Synthetic Cells: Paper

A Stat News opinion column argues the need for FDA and those working on synthetic cell therapies to open talks on an appropriate regulatory framework.

Human Drugs

FDA Accepts Biogen Tofersen NDA for Rare ALS

FDA accepts a Biogen NDA for tofersen to treat a rare form of ALS and grants it priority review.

Human Drugs

FDA Grants Taiho Oncology Lonsurf Petition

FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.

Human Drugs

Many Supplements Stay on Market After FDA Warning

Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.

Medical Devices

Northeast Scientific 510(k) for Reprocessing Laser Catheter

FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, which is used to tre...

Medical Devices

Biotronik Pulsar-18 T3 Stent Approved

FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation procedures for endov...

Human Drugs

Antibacterial Therapy Guidance Comments

Two drug companies comment on an FDA draft guidance on antibacterial therapies.

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Federal Register

Orange Book Questions & Answers Guide

Federal Register notice: FDA makes available a final guidance entitled Orange Book Questions and Answers.