Laurel, MD (PRWEB) December 24, 2009
Prophetic Consulting LLC (http://www.profeticconsult.com) a leading provider of independent investment research and biotech stocks news on small and micro-cap biotechnology and pharmaceutical companies provides latest event updates on its FDA & Biotech calendar for (TSPT), (CTIC), (ACOR), (OSIP), The following updates were made:
TransceptPharmaceuticals, Inc. (Nasdaq: TSPT) is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual tablet).
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that on February 10, 2010 the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for pixantrone for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) is developing Tarceva and the drug's NDA is currently under review. Tarceva(R) (erlotinib) is being developed for use as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. The FDA Prescription Drug Fee Act (PDUFA) review date for the Tarceva application is on or about January 18, 2010
Acorda Therapeutics, Inc. (Nasdaq: ACOR) expects a decision from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for Fampridine-SR to January 22, 2010. Fampridine-SR is being developed to improve walking ability in people with Multiple Sclerosis (MS)
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