A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to...
Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating roo...
FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its sterile drug manufacturing...
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a commentary published by S...
FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading claims about compoun...
Neumora Therapeutics discontinues development of its lead depression candidate navacaprant after two Phase 3 studies failed to meet their primary and ...
A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.
