Strides gets US FDA nod for Lamivudine-Stavudine combo (PharmaBiz)
Strides Arcolab Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for one new drug application (NDA) for fixed dose combination of Lamivudine and Stavudine Tablets 150 mg / 30 mg under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).

FDA Approves Label Change For Non-Invasive Fibroid Treatment - Allows Doctors To Use ExAblate(R) To Treat Up To 100% ... (Medical News Today)
InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids.