FDA places a clinical hold on an unidentified Immuron investigational drug being evaluated for treating campylobacter and enterotoxigenic escherichia ...
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.