FDA clears an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroximel fumarate), indicat...
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.