Posted On: 04/26/2013 8:46:09 PM
Post# of 63831
FDA list.
| Date | Company Name | Ticker | Drug | Event | Outcome | Details | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 06/15/2013 | Delcath Systems Inc. | DCTH | CHEMOSAT with melphalan hydrochloride (NDA resubmission) | FDA decision on CHEMOSAT with melphalan hydrochloride for metastatic melanoma in liver | | ||||||
| 05/22/2013 | Merck & Co Inc. | MRK | Suvorexant tablets (NDA) | FDA panel to review Suvorexant for for insomnia | | ||||||
| 05/12/2013 | GlaxoSmithKline PLC | GSK.L, GSK | BREO ELLIPTA (NDA) | FDA decision on BREO ELLIPTA for chronic obstructive pulmonary disease | | ||||||
| 05/12/2013 | THERAVANCE, INC. | THRX | BREO ELLIPTA (NDA) | FDA decision on BREO ELLIPTA for chronic obstructive pulmonary disease | | ||||||
| 05/02/2013 | AVEO Pharmaceuticals, Inc. | AVEO | Tivozanib (NDA) | FDA panel to review Tivozanib for advanced renal cell carcinoma | | ||||||
| 04/30/2013 | TITAN PHARMACEUTICALS INC | TTNP.OB | Probuphine (NDA) | FDA decision on Probuphine for the maintenance treatment of adult patients with opioid dependence | | ||||||
| 04/30/2013 | Navidea Biopharmaceuticals, Inc. | NEOP , NAVB | Lymphoseek (NDA resubmission) | FDA decision on Lymphoseek for use as diagnostic tracing agent in lymphatic mapping procedures | FDA approved Lymphoseek for use in lymphatic mapping on Mar.13, 2013 | | |||||
| 04/30/2013 | Raptor Pharmaceuticals Corp. | RPTP | RP103 (NDA | FDA decision on RP103 for potential treatment of nephropathic cystinosis |
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