FDA Approvals - Japan, U.S. To Review Pfizer's Fast Track Crizotinib Cancer TreatmentConfident
Japan, U.S. To Review Pfizer's Fast Track Crizotinib Cancer Treatment
Confident Pfizer Incorporated announced today that it will submit its new drug crizotinib for approval both to the FDA and the Japanese Ministry of Health, Labor and Welfare (MHLW) after receiving "fast track" status by the FDA in 2010. Crizotinib is the first of its kind of medication intended to treat cellular lung cancer (NSCLC). Garry Nicholson, president and general manager, Pfizer Oncology ...
FDA Warns About Counterfeit ExtenZe Dietary Supplements
The U.S. Food and Drug Administration is warning consumers about a potentially harmful product represented as "ExtenZe," a dietary supplement for male sexual enhancement. The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers...
FDA Grants Fast Track Designation To Bayer's Investigational Compound Regorafenib For The Treatment Of ...
Bayer HealthCare Pharmaceuticals Inc. announced today that its investigational compound regorafenib (BAY 73-4506) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite at least imatinib and sunitinib as prior treatments ...