There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars:
Amylin Pharma (NASDAQ: AMLN), Eli Lilly (NYSE: LLY), and Alkermes (NASDAQ: ALKS) announced today that a NDA was filed for FDA approval of a once-weekly version of exenatide (Byetta LAR) as once weekly formulation for type 2 diabetes which is administered by subcutaneous injection.
Cell Therapeutics (NASDAQ: CTIC) announced today that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive non-Hodgkin's lymphoma that has either relapsed or is refractory to standard treatment options.
A full report on the developments and how they affect upcoming FDA decisions and approvals is available on the BiomedReport's FDA Calendar, which includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
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