New Drug Applications Archive - August 2012
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August 1, 2012
- Hemispherx Biopharma Files Complete Response With the FDA Regarding Its Ampligen New Drug Application for Chronic Fatigue Syndrome
- pSivida Corp. Reports Alimera's Intention to Resubmit Application to FDA for Iluvien in DME Using Data from Completed Trials
August 2, 2012
August 13, 2012
- NPS Pharmaceuticals Announces Extension of Action Date for Gattex NDA to December 30, 2012
- Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
- Santarus Announces FDA Extension of Uceris New Drug Application Target Action Date to January 16, 2013
August 14, 2012
August 17, 2012
August 20, 2012
August 21, 2012
- U.S. Food And Drug Administration Extends Action Date For Tofacitinib New Drug Application By Three Months
- NPS Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Gattex (teduglutide)
August 24, 2012
August 27, 2012
- Genzyme Provides Update on U.S. Lemtrada Filing
- New Novartis Phase II data Show LCZ696 May Provide Clinical Benefits in Patients with a Difficult-to-Treat Form of Heart Failure
August 29, 2012
- Dynavax Announces FDA Advisory Committee to Review Heplisav
- Noven Submits New Drug Application for Investigational Non-Hormonal Therapy for Menopausal Vasomotor Symptoms
