[ad_1] PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ — RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, announced that the US Food and Drug Administration (FDA) has […]
Tag: FDA Approval
FDA Approves New Treatment for Hemophilia A or B
[ad_1] Product is First Non-Factor and Once-Weekly Treatment for Hemophilia B SILVER SPRING, Md., Oct. 11, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or […]
Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth Syndrome USA – English USA – English
[ad_1] Advisory Committee Voted 10 to 6 in Favor, Concluding that Elamipretide is Effective for the Treatment of Barth Syndrome Elamipretide NDA Received Priority Review with a PDUFA Action Date of January 29, 2025 If Approved, Elamipretide […]
Natus seeks FDA 510(k) clearance for its highly anticipated point-of-care EEG solution
[ad_1] MIDDLETON, Wis., Oct. 10, 2024 /PRNewswire/ — Natus Medical Incorporated announced it has submitted an FDA 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its Natus point-of-care EEG device. The […]
Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687
[ad_1] COPENHAGEN, Denmark, Oct. 9, 2024 /PRNewswire/ — Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity, today announced that the U.S. Food […]
