Nuvo Research Inc. (NRI) TSE Calendar: FDA Calendar east234
Request Reminder for this Event 08-05-2009 *The times shown may change, depending on DST settings The FDA is expected to rule on Pennsaid by Aug. 5, 2009
FDA NDA decision date - NeurogesX, Inc. (NGSX) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 08-16-2009 *The times shown may change, depending on DST settings Qutenza for pain in postherpetic neuralgia (PHN) was given a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009
FDA decision date - Cell Therapeutics (CTIC) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 08-24-2009 *The times shown may change, depending on DST settings CTIC FDA decision date of Aug 24, 2009
S E P T E M B E R
FDA NDA decision date - Spectrum Pharmaceuticals (SPPI) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 09-07-2009 *The times shown may change, depending on DST settings FDA Accepts for Review Spectrum Pharmaceuticals, Inc. (SPPI)'s Response on ZEVALIN as a Class 1 Submission, and Establishes September 7, 2009 as Decision Date
SLXP-Nasdaq Approval Date September 11 Calendar: FDA Calendar Lucifer
Request Reminder for this Event 09-11-2009 *The times shown may change, depending on DST settings FDA Approval Date September 11 Q2 Earning Announcement August 4
ISTA - Nasdaq Approval Date September 12 2009 Calendar: FDA Calendar Lucifer
Request Reminder for this Event 09-12-2009 *The times shown may change, depending on DST settings ISTA FDA Approval Date September 12, 2009 Current price is attractive for entry in my opinion Good Luck
FDA NDA decision date - Telavancin (THRX) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 09-16-2009 *The times shown may change, depending on DST settings The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of complicated skin and skin structure infections (cSSSI)
FDA NDA decision date - Johnson & Johnson (JNJ) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 09-20-2009 *The times shown may change, depending on DST settings I dont like putting the big pharma's on the calendar here since the price moves on FDA decision are not as big as smaller biotech stocks.
But anyways here they are with the drug Yondelis (trabectedin) that is pending a NDA decison from the FDA 9/20/09.
FDA NDA decision date - Allos Therapeutics (ALTH) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 09-24-2009 *The times shown may change, depending on DST settings awaiting FDA approval with a 09/24/2009 PDUFA date for the tratment of pTCL which is a subtype of Non-Hodgkin's Lymphoma (NHL)
S E P T E M B E R -- FDA Calendar + 1 D E C E M B E R
I performed the same research last weekend. Missing from your list are: -VVUS (Sept) -CXM (Sept) -PSDV (Dec) -TDLP (Sept)
Great information sharing and good positive forum.
Archi
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O C T O B E R - 22nd - BIIB + ACOR
FDA decision -Biogen Idec (BIIB) and Acorda Therapeutics (ACOR) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 10-22-2009 *The times shown may change, depending on DST settings Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercialize Fampridine-SR
The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009; the PDUFA date is the target date for the FDA to complete its review of Fampridine-SR for MS/ME.
Biogen Idec has outstanding capabilities in commercializing neurology and oncology products and is known globally for its reputation as an innovative leader in the field of multiple sclerosis. We are delighted to be working with them to make Fampridine-SR, if approved, available to people living with MS in Europe, Canada, Australia and other areas of the world," said Ron Cohen, M.D., President and CEO of Acorda. "We believe that Biogen Idec's international expertise in MS and neurology also will help us optimize future development of Fampridine-SR and maximize its value in markets outside the U.S."
OCTOBER 30. 2009 : GTXI + TSPT
GTXI - Nasdaq Approval Date October 30 2009 Calendar: FDA Calendar Lucifer
Request Reminder for this Event 10-30-2009 *The times shown may change, depending on DST settings GTXI FDA Approval Date Oct 30 2009 Q2 Earning on August 4 2009 Price has been steadily climbing recently Good luck
FDA NDA decision date - Transcept (TSPT) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 10-30-2009 *The times shown may change, depending on DST settings Transcept Pharmaceuticals, Inc. (Public, NASDAQ:TSPT)
The U.S. Food and Drug Administration (FDA) has established October 30, 2009 as its target date under PDUFA (the Prescription Drug User Fee Act) to take action on its review of the New Drug Application (NDA) for Intermezzo(R). Transcept is actively pursuing patents to protect Intermezzo(R) in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R).
N O V E M B E R ..FDA Calendar
FDA NDA decision date - Cadence Pharma (CADX) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 11-13-2009 *The times shown may change, depending on DST settings The FDA has issued a PDUFA decision date for the NDA of 11/13/09. This application for Acetavance (intravenous acetaminophen) was granted priority review for the treatment of acute pain and fever in adults and children
FDA NDA decision date - CombinatoRx (CRXX) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 11-22-2009 *The times shown may change, depending on DST settings CombinatoRx, Incorporated (Public, NASDAQ:CRXX)
Neuromed has filed a New Drug Application for Exalgo with the FDA, which has a November 22, 2009 PDUFA review date.
FDA NDA decision date - Theravance (THRX) Calendar: FDA Calendar FavStocks
Request Reminder for this Event 11-26-2009 *The times shown may change, depending on DST settings FDA decision date is 11/26/09 for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP). This triggers a milestone payment of $10M from THRX's partner, Astellas Pharma (ALPMF.PK).
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