FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work testing drugs and act...
FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.
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...
FDA approves an Eisai/Biogen at-home injection option for Alzheimers treatment Leqembi (lecanemab), expanding access to patients in the early stages o...
FDA approves a Foresee Pharmaceuticals NDA for Camcevi ETM (leuprolide mesylate), a once every three-month injectable formulation for treating advance...
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...
