Federal Register notice: FDA makes available a draft guidance entitled Assessing User Fees under the Generic Drug User Fee Amendments of 2017.
President Donald Trump chooses to nominate MD Anderson chief medical officer Stephen Hahn to be FDA commissioner.
Federal Register notice: FDA has announced a 12/10 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Correvio International NDA f...
Novartis says its EXCEED head-to-head trial comparing Cosentyx (secukinumab) to AbbVies Humira (adalimumab) in patients with active psoriatic arthriti...
An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine found in ranitidine (Zantac) says that preliminary testi...
FDA clears an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventional procedures.
Thoratec Switzerland recalls its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorporeal Blood Pumping ...
Federal Register notice: FDA determines that Boehringer Ingelheims Mexitil (mexiletine hydrochloride) was not withdrawn from sale for safety or effect...