New Drug Applications Archive - June 2012
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June 1, 2012
June 6, 2012
June 7, 2012
- Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
- ThromboGenics Receives Notice From FDA of Advisory Committee Meeting for Ocriplasmin
June 12, 2012
- Genzyme Submits Applications to FDA and EMA for Approval of Lemtrada (alemtuzumab) for Multiple Sclerosis
- Tokai Pharmaceuticals' Galeterone Receives Fast Track Designation from the FDA for the Treatment of Advanced Prostate Cancer
June 15, 2012
June 18, 2012
June 19, 2012
June 21, 2012
- Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC)
June 25, 2012
- MAP Pharmaceuticals Provides Update Following Meeting with FDA for Levadex (dihydroergotamine) New Drug Application
- Bristol-Myers Squibb and Pfizer Receive Complete Response Letter From U.S. Food and Drug Administration for Eliquis (Apixaban)
- Repligen Receives Complete Response Letter from FDA for RG1068 NDA
June 27, 2012
- Dynavax Announces FDA Acceptance of Heplisav BLA
- Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients
- QRxPharma Receives Complete Response Letter From FDA Regarding MoxDuo NDA
