FDA grants de novo authorization for Caristo Diagnostics CaRi-Heart coronary inflammation technology.
An FDA advisory committee votes against recommending approval for Capricor Therapeutics' investigational cell therapy deramiocel, for treating cardiom...
Two Latham Watkins attorneys analyze a revised FDA draft guidance on demonstrating substantial evidence of effectiveness in drug and biologic trials a...
FDA releases the form FDA-483 with three observations from an inspection at the Hayward, CA-based Allure Labs drug manufacturing facility.
FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate deh...
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in Bangalore.
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year were indicated for use...
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ...
