FDA– tag –
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Atrium Therapeutics Receives FDA IND Clearance for RNA Therapeutic ATR 1072 to Treat PRKAG2 Syndrome, Advancing to Phase 1/2 Corventis Trial
Clival Database USA Overview Atrium Therapeutics announced FDA Investigational New Drug (IND) clearance for ATR 1072, an RNA therapeutic in development for the rare PRKAG2 syndrome. This clearance allows the company to proceed with the P... -
Widespread Global Disparities in CAR T-Cell Therapy Access Highlighted; In Vivo CAR-T, Allogeneic Platforms, and Rapid Manufacturing Emerge as Potential Solutions
ASH Clinical News USA Overview Significant global disparities in CAR T-cell therapy access are attributed to high costs, manufacturing complexities, and limited healthcare infrastructure. Novel scientific strategies, including in vivo CA... -
OXB Accelerates Gene Therapy Production for Plowshare Therapies, Leveraging FDA-Approved AAV Manufacturing in North Carolina
Markets Insider UK Overview OXB has partnered with Plowshare Therapies to provide crucial process development and GMP manufacturing for Plowshare’s AAV gene therapy program. This collaboration leverages OXB's FDA-approved commercial-scal... -
Umoja Biopharma Secures FDA IND Clearance for UB-VV400, First-in-Industry CD22-Targeted In Vivo CAR T Cell Therapy for Relapsed/Refractory B-Cell Malignancies
Umoja Biopharma (Press Release) USA Overview Umoja Biopharma has received FDA Investigational New Drug (IND) clearance for UB-VV400, a CD22-targeted in vivo CAR T cell therapy candidate for relapsed/refractory B-cell malignancies. This m... -
Dexcom Selected as First Participant in FDA’s TEMPO Pilot Program to Advance AI-Powered Glucose Health for Early Prediabetes & T2D Intervention
Business Wire (via Dexcom Investor Relations) USA Overview Dexcom has been selected as the inaugural participant in the FDA's TEMPO (Technology-Enabled Meaningful Patient Outcomes) digital health devices pilot program, aiming to accelera... -
FDA Selects Dexcom as First Participant in ‘TEMPO’ Digital Health Pilot Program
MedTech Dive USA Overview The FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot Program. This pilot will enable Dexcom to implement an AI-enabled glucose health progr... -
Withings Introduces Abbott’s Lingo Biosensor for Non-Invasive Glucose Management, Targeting 70-140 mg/dL Range
Withings France Overview Withings introduces Abbott's Lingo as a non-invasive continuous glucose monitor (CGM) biosensor. Lingo painlessly attaches to the upper arm, streaming real-time glucose data to the Lingo app. This allows users to... -
Dexcom’s Stelo Achieves OTC Approval, Leading CGM Market for Non-Insulin Type 2 Diabetes Patients
CNET USA Overview Dexcom's Stelo has received FDA over-the-counter (OTC) approval, establishing it as a market leader in continuous glucose monitoring (CGM) for non-insulin users with Type 2 diabetes. The device provides real-time glucos... -
Qatar Issues Stark Warning Against Unapproved Injectable Exosomes, Citing Lack of Scientific Basis and Safety Data
ILoveQatar.net Qatar Overview The Qatar Ministry of Public Health has issued a strong public warning against the use of unapproved injectable exosome products for both medical and cosmetic applications. The Ministry explicitly stated tha... -
Regeneron to Seek Approval for Hearing Loss Gene Therapy Following “Game-Changing” Clinical Data
BioPharma Dive USA Overview Regeneron plans to seek regulatory approval for its gene therapy for rare genetic hearing loss, based on "game-changing" clinical trial data published in the New England Journal of Medicine. The therapy demons...
