FDA agrees to accept a biosimilar application to compete with Johnson & Johnsons Stelara that does not include clinical efficacy studies for a monoclo...
FDA clears a Medtronic 510(k) for its MiniMed 780G insulin delivery system to integrate with Abbotts Instinct continuous glucose monitoring sensor for...
HHS says FDA is removing members of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) and Childrens Hospital of Philadelphias V...
Johnson & Johnson decides to stop development of nipocalimab in combination with an anti-tumor necrosis factor alpha therapy for rheumatoid arthritis ...
Novocure stops its LUNAR-4 study, a Phase 2 open-label trial testing Tumor Treating Fields together with Mercks Keytruda (pembrolizumab) in lung cance...
FDA approves an expanded use for Medtronics Evolut transcatheter aortic valve replacement system, allowing implantation of a new Evolut valve inside a...
Ambu recalls (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non-functional.
Hamilton Medical recalls (Class 1) certain lots of coaxial breathing sets due to a quality issue involving a defective blade in the tube-cutting stage...
