FDA Approvals - Alseres Receives Special Protocol Assessment Agreement From FDA For Phase
Alseres Receives Special Protocol Assessment Agreement From FDA For Phase III Trial Of Altropane (Medical News Today)
Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) announced that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the Phase III protocol of Alseres' Altropane(R) Molecular Imaging Agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease.
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.
FDA Warns 14 Pharmaceutical Companies About Short Internet Ads That Do Not Contain Risk Information (Medical News Today)
FDA has warned 14 major pharmaceutical firms about brief Internet advertisements that could have misled patients because they did not include information about health risks related to the drugs, according to letters posted to the agency's Web site Friday, the Wall Street Journal reports.