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 reduce […]
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 Would […]
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 rapid […]
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 and […]
Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ — Johnson & […]