Posted On: 04/07/2013 11:43:01 AM
Post# of 63859
FDA.
| 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 , GSK.L | 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 | Raptor Pharmaceuticals Corp. | RPTP | RP103 (NDA | FDA decision on RP103 for potential treatment of nephropathic cystinosis | | ||||||
| 04/30/2013 | Navidea Biopharmaceuticals, Inc. | NAVB , NEOP | 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 | | |||||
| 04/17/2013 | THERAVANCE, INC. | THRX | BREO ELLIPTA (NDA) | FDA panel to review BREO ELLIPTA for for chronic obstructive pulmonary disease | | ||||||
| 04/15/2013 | MAP PHARMACEUTICALS, | MAPP | LEVADEX (NDA) Resubmission | FDA decision on LEVADEX for acute treatment of migraine in adults | | ||||||
| 03/31/2013 | United Therapeutics Corp | UTHR | Oral Treprostinil (NDA resubmission) | FDA decision on oral Treprostinil for treatment of pulmonary arterial hypertension. | FDA issued complete response letter oral Treprostinil on March 25, 2013 | | |||||
| 03/31/2013 | Johnson & Johnson | JNJ | Canagliflozin (NDA) (Trade name INVOKANA) | FDA decision on INVOKANA for treatment of type 2 diabetes in adult patients | FDA approved INVOKANA on Mar.29, 2013 |
| |||||
| 03/27/2013 | AP Pharma Inc | APPA.OB | APF530 (NDA resubmission) | FDA decision on APF530 for prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting. | FDA issued complete response letter for APF530 on March 28, 2013 | | |||||
| 03/27/2013 | Ariad Pharmaceuticals Inc | ARIA | Ponatinib (NDA) | FDA decision on Ponatinib for patients with resistant or intolerant chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia | FDA granted accelerated approval for Iclusig (Ponatinib) on Dec.14, 2012 |
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