U.S. FDA Approves Anti-Epileptic Agent Banzel (Rufinamide) Oral Suspension, 40mg/Ml
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") and its U.S. subsidiary Eisai Inc. announced that the United States Food and Drug Administration (FDA) approved the company's anti-epileptic agent BANZEL (rufinamide) Oral Suspension, 40 mg/ml on March 3 (U.S. local time) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children ...

FDA's Office Of New Drugs Meets With Cell Therapeutics On Its Appeal On Pixantrone
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that it has met with officials of the FDA's Office of New Drugs ("OND") in Maryland and presented its arguments supporting the Company's belief that the data contained in its New Drug Application ("NDA") 22-481 support the conclusion that pixantrone is effective for its planned use. "We appreciate OND's consideration of our appeal...

FDA Applications and a Look Ahead
It isn't pretty.