July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued certain observations regarding violations in the company's manufacturing plant in Taiwan.
The FDA clears Sorin Group's ( OTC:SORJF ) Solo Smart Aortic Pericardial Heart Valve. It is the first valve with a removable stent approved in the U.S. The product is designed from bovine pericardium. Post your comment!
Masimo's (NASDAQ: MASI ) Radius-7 wireless patient monitor receives CE Mark clearance in Europe. The company is proceeding with a limited market release of the product. It has not yet been cleared by the FDA . Post your comment!
drug , Eloctate, for the treatment of Hemophilia A in the United States for both adults and children. Biogen also received the FDA approval for its Hemophilia B's therapy, Alprolix, a few months ago. Let's take a look at the prevailing market of Hemophilia
July 29 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan.
The FDA grants 510(k) clearance to Teleflex (NYSE: TFX ) subsidiary Hotspur Technologies' Arrow GPSCath Balloon Dilation Catheter
In response to the FDA 's September 6, 2013 not-approvable letter, Guided Therapeutics ( OTCQB:GTHP +0.8% ) files an amendment to its PMA application
By M Plaut : When Provectus Biopharmaceuticals Inc. (NYSEMKT: PVCT ) announced at the end of May that the FDA had denied it Breakthrough Therapy Designation (BTD) it caused a sharp drop in the stock price. The extreme move in the stock
Shares of EDAP TMS S.A. ( EDAP -21.5% ) drop on a 3x surge in volume. Earlier today, the FDA released its briefing documents for Wednesday's meeting of the Gastroenterology and Urology Devices Panel. The Committee will
might find MannKind's (NASDAQ: MNKD ) FDA approval as a good time to short the stock ..... MannKind bulls didn't seem to think that an FDA approval would go through without a partnership ..... success immediately after their drug's FDA approval. I also made the point that a