FDA Clears Biora's IND Application For BT-600 In Ulcerative Colitis Treatment
BT-600 is a drug/device combination designed to use Biora's NaviCap ingestible drug delivery device with a proprietary liquid formulation of tofacitinib, for the treatment of moderate to severe ulcerative colitis. The NaviCap device has been designed for targeted delivery directly to the colon in this application.
FDA clears BrainSpec’s tool to measure metabolites on brain scans
The U.S. Food and Drug Administration (FDA) has cleared BrainSpec Core, a platform that performs non-invasive measurements of brain chemistry, for use in diagnosing some of the most common diseases that affect the brain, including multiple sclerosis (MS).
Lupin obtains FDA OK for generic Bromfenac, tentative nod for generic Invokana
Generic Bromfenac Ophthalmic Solution is indicated for the treatment of post operative inflammation and reduction of ocular pain in patients who have under gone cataract surgery.
FDA recommends avoiding plastic syringes made in China amid safety investigation
The FDA is advising U.S. healthcare providers and patients to stop using any plastic syringes in their inventories that were made in China, if possible, as it looks into a spate of quality complaints.
AHA comments on FDA proposed rule for laboratory developed tests
American Hospital Association urged the Food and Drug Administration not to apply its device regulations to hospital and health system laboratory developed tests.
FDA clears GRI Bio’s Phase 2 trial of natural killer T-cell targeted therapy
The U.S. Food and Drug Administration (FDA) has given GRI Bio the green light to conduct a Phase 2 trial of its investigational natural killer T-cell (NKT)-targeted therapy, GRI-0621, in people with idiopathic pulmonary fibrosis (IPF).
FDA grants orphan status to Edgewise’s muscular dystrophy drug
The U.S. Food & Drug Administration has granted Orphan Drug Designation for a drug produced by Edgewise Therapeutics for the treatment of Duchenne and Becker muscular dystrophy.
FDA accepts Merck’s Keytruda plus Padcev sBLA to treat urothelial cancer
The US Food and Drug Administration (FDA) has accepted Merck’s new supplemental biologics licence application (sBLA) for anti-PD-1 therapy Keytruda plus antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial carcinoma (la/mUC), for review.
Balance of Nature says it is back in business after FDA shutdown
Balance of Nature says it has resumed selling and shipping its dietary supplements, following a court-ordered pause of its operations earlier this month over concerns raised by the Food and Drug Administration.
Illinois medical school makes history with FDA-cleared hologram tech for patient treatment
The Carle Illinois College of Medicine at the University of Illinois Urbana-Champaign is the first in the world to use hologram technology to treat patients. It’s called MediView XR and it was just cleared by the Food and Drug Administration.