Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 2025, noting that the ...
A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect access to medication...
FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, India.
FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate...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 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.
FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufacturing facility.
