Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-stage clinical trials...
FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant metastatic colorectal...
Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 2025, noting that the ...
FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate...
As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival primary endpoint in a ...
FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, India.
FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra LifeSciences.
FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.
