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BiomedReports.com Tracks FDA Calendar Updates for AMAG Pharma and Immunomedics - There are FDA calendar updates for AMAG Pharma (NASDAQ: AMAG), Immunomedics (NASDAQ: IMMU)
BiomedReports.com Tracks FDA Calendar Updates for AMAG Pharma and Immunomedics

 

NewswireToday - /newswire/ - Pasadena, CA, United States, 2009/05/13 - There are FDA calendar updates for AMAG Pharma (NASDAQ: AMAG), Immunomedics (NASDAQ: IMMU).

   
 
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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.

About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.

Certain sections of this report contain forward-looking statements that are based on our reporters' expectations, estimates, projections and assumptions. Words such as "expects," "anticipates," "plans," "believes," "scheduled," "estimates" and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.

All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company's behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.

 
 
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BiomedReports.com Tracks FDA Calendar Updates for AMAG Pharma and Immunomedics

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Publisher Contact: M. Garza - BioMedReports.com 
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