AngioScore Receives FDA Clearance To Market AngioSculpt PTA Scoring Balloon Catheter For Additional Peripheral ... (Medical News Today)
AngioScore, Inc., a developer of novel angioplasty catheters for use in the treatment of cardiovascular disease, announced that its AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter has received U.S.

FDA and the Paul Ehrlich Institute (Germany) Approve Pluristem's Regulatory Submissions in Support of a Phase I/II ... (Centre Daily Times)
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that the Paul Ehrlich Institute (PEI) in Germany has approved the pre-clinical study synopsis to support a Phase I/II clinical trials in Germany ...

FDA Official Pulls Back On Estimates Of Cost To Inspect Foreign Drug Makers Properly (Medical News Today)
FDA Center for Drug Evaluation and Research Director Janet Woodcock on Thursday during a House hearing "backed away" from a Tuesday comment that the agency would need an estimated $225 million to improve inspections of foreign medication manufacturing plants, the Wall Street Journal reports (Mundy, Wall Street Journal, 5/2).