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FDA Calendar Updates: POZN, AZN, SNY, CEPH, APPY, CYTR
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<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-st>...
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FDA Calendar Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH)
CEPH
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<> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . The 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 fo>...
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FDA Calendar Updates: SNTS, CEPH, AZN, DNDN, GILD, NVO
CEPH
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<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 112 entries through 4/6/09. The FDA Calendar includes the following information: company name, ticker>...
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Updated Clinical Trial and FDA Decision Calendars
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<> <> Updated Clinical Trial and FDA Calendars Below is a summary of updates to the www.BioMedReports.co <wbr> </wbr> m database of 243 entries included in the FDA and Clinical Trial Calendars. http://biomedreports <wbr> </wbr> .com/fda-calendar.ht <wbr> </wbr> ml The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 104 entries through today. The FDA Calend>>...
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A New Index of Health Product Innovators
CEPH
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<> The accompanying table includes statistics and all 23 companies in the ETF Innovators [ETFI] Global Health Innovators Index of companies with market caps over $250M which received FDA approval in the past 12 months for an original new drug product or medical device. The index includes companies which get approvals for drugs or biological agents classified as new chemical entities (i.e. excluding all new formulations of existing drugs, generic drugs, and label extensions for existing products). Also, companies whi>...
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