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FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate...
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.
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 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufacturing facility.
IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neurological symptoms in ...
