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FDA clears a Bovie Medical 510(k) for six new hand piece configurations that expand its J-Plasma pistol grip surgical device.[ Price : $8.95]
Lipocine files a 505(b)(2) NDA for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult...[ Price : $8.95]
CVM issues a guidance on Two-Phased Chemistry, Manufacturing, and Controls (CMC) that provides recommendations on submitting such ...[ Price : $8.95]
Duchesnay says it has taken corrective action to address an 8/7 Warning Letter from CDERs Office of Prescription Drug Promotion th...[ Price : $8.95]
Amarin and FDA agree to discuss a settlement after the company earlier this month was granted preliminary relief in its First Amen...[ Price : $8.95]
FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid for treating primary biliary cirrhosis.[ Price : $8.95]
FDA approves a Sunshine Heart protocol amendment to modify the stopping rule criteria for the company's COUNTER HF pivotal study f...[ Price : $8.95]
Insulet Corp. recalls 400,000 units of its OmniPod (Pod) Insulin Management System, citing the possibility that some devices may h...