FDA: Consumer Electronics May Impact Implanted Medical Devices
The FDA is advising patients with implanted medical devices to consider keeping consumer electronics at least 6 inches away from the implanted medical device.
The FDA is advising patients with implanted medical devices to consider keeping consumer electronics at least 6 inches away from the implanted medical device.
BBP-631 is an adeno-associated virus 5 (AAV5) gene therapy designed to deliver a functional copy of the 21-hydroxylase gene to restore the body’s ability to produce cortisol and aldosterone.
Fully vaccinated individuals may resume indoor and outdoor activities without wearing masks or physical distancing, except under certain circumstances.
LB1148 is an oral formulation of a broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases released from the gut during surgery.
The NDA submission includes data from the phase 3 SONICS and LOGICS studies that evaluated levoketoconazole in adults with endogenous Cushing syndrome.
The needle-free product is intended for single-dose administration only.
EVO100 is pH-modulating vaginal gel designed to reduce certain vaginal infections by balancing vaginal pH, thereby maintaining healthy vaginal flora.
Losmapimod is a selective p38α/β mitogen activated protein kinase inhibitor that works by reducing the expression of the DUX4 gene in muscle cells.
The product samples are being recalled because they were stored at temperatures below storage requirements.
The BLA submission is supported by data from the PATHFINDER clinical program.