Resmed recalls its Astral 100/150 ventilator system due to the potential for a supercapacitor electrolyte leakage on the printed circuit board assembl...
Bloomberg reports that Centers for Medicare & Medicaid Services head Mehmet Oz is increasingly viewed inside the Trump administration as the leading c...
FDA issues Dr. Reddys a three-observation Form FDA-483 following a pre-approval inspection and Good Manufacturing Practices inspection at the companys...
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...
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...
