There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars.
The site's FDA Calendar 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.
AMAG has announced that the FDA accepted the Company's resubmission of its Feraheme™ (ferumoxytol injection) New Drug Application in response to the December 2008 Complete Response letter as a complete, Class 1 response with a PDUFA date of 6/29/09.
Immunomedics provided several updates for its clinical development pipeline.
A full, detailed report on the developments and how they affect upcoming FDA decisions and approvals is available online.
Disclosure: No positions.
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