Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treating Covid-19 because ...
Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.
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.
FDA accepts a Biogen NDA for tofersen to treat a rare form of ALS and grants it priority review.
FDA grants a Taiho petition restricting generic forms of its Lonsurf cancer drug.
Researchers say FDA needs to strengthen enforcement against dietary supplements that contain prohibited ingredients.
FDA clears a Northeast Scientific 510(k) for reprocessing Philips Spectranetics 0.9mm OTW Turbo-Elite laser atherectomy catheter, which is used to tre...
FDA approves a Biotronik PMA for its Pulsar-18 T3 peripheral self-expanding stent system that is intended to improve implantation procedures for endov...
