FDA clears a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma ...
Macleods Pharmaceuticals recalls one lot of losartan potassium/hydrochlorothiazide 100mg/25mg combination tablets due to an impurity level concern.
A new FDA safety alert warns about Pfizers tofacitinib (Xeljanz, Xeljanz XR) after a clinical trial found an increased risk of blood clots in the lung...
FDA Review posts the Federal Register notices for the week ending 2/22/2019.
FDA Review posts product approval summaries for the week ending 2/22/2019.
FDA posts a draft guidance entitled Implanted Brain-Computer Interface (BCI) 1 Devices for Patients with Paralysis or Amputation Non-clinical Testing...
FDA grants Imbrium Therapeutics an orphan drug designation for its investigational drug etoposide toniribate, intended for treating relapsed refractor...
FDA accepts for review an Alexion Pharmaceuticals supplemental BLA for the use of Soliris (eculizumab) in treating certain patients with neuromyelitis...