Category Archives: Approval Announcements

More on the Complete Response Letter Track Record and Stock Impact

Last week, I ran a chart on the track record of Complete Response Letters versus approvals from the FDA, demonstrating that the latter is losing in favor of the former.  Since then, the balance of power has changed even further. … Continue reading

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Full Disclosure on Complete Response Letter by Targanta

Companies take various approaches to revealing the information that is contained in a Complete Response Letter from the FDA, but Targanta Therapeutics Corporation (NASDAQ:  TARG) was very thorough in its press release this week.  It is not uncommon for small … Continue reading

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Cephalon Receives FDA Approval for TREANDA to Treat Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma

Cephalon had an approval announcement today that is worth sharing, not only from the clinical point of view, but from a communications point of view.  It is an example of a smart announcement and one that demonstrates the growing importance … Continue reading

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