RedHill Biopharma Ltd. (RDHL) Announces FDA Acceptance for Review of RHB-103 NDA for Acute Migraine and PDUFA Goal Date of February 3, 2014
6/18/2013
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Alimera Sciences (ALIM) Announces New PDUFA Date for ILUVIEN®
5/1/2013
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QRxPharma Pty Ltd. Sets PDUFA Date for MOXDUO® NDA
3/14/2013
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Hyperion Therapeutics Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti™
1/16/2013
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Pfizer Inc. (PFE)/Ligand Pharmaceuticals Inc. (LGND) Get PDUFA Date for Menopause Combo
12/14/2012
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Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug
10/19/2012
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FDA Extends Review of Biogen Idec, Inc. (Massachusetts) (BIIB) MS Drug
10/18/2012
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A.P. Pharma, Inc. (APPA) Announces PDUFA Action Date for APF530 New Drug Application Resubmission
10/16/2012
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Impax Pharmaceuticals (IPXL): FDA Extends Review on Rytary NDA
10/12/2012
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GlaxoSmithKline (GSK), Theravance, Inc. (THRX): FDA OK for FF/VI
9/27/2012
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Hyperion Therapeutics Announces Extension of Action Date for Ravicti™ NDA to January 23, 2013
9/6/2012
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Medivation, Inc. (MDVN) and Astellas Pharma Inc. (YPH.BE) Get PDUFA Date for Prostate Cancer Drug
8/6/2012
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FDA Grants Priority Review for Exelixis, Inc. (EXEL)'s Cabozantinib in Medullary Thyroid Cancer
7/30/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Announces Adasuve PDUFA Goal Date Of Dec. 21, 2012
7/6/2012
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Consumer Group Urges FDA to Reject Arena Pharmaceuticals, Inc. (ARNA) Diet Drug
6/28/2012
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Eli Lilly and Company (LLY) Statement on PDUFA Vote by Senate
6/27/2012
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If Arena Pharmaceuticals, Inc. (ARNA)'s Lorcaserin is Approved, Buy VIVUS, Inc. (VVUS)
6/27/2012
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FDA Receives Repros Therapeutics Inc. (RPRX)' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R)
5/17/2012
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Arena Pharmaceuticals, Inc. (ARNA) Wins Positive FDA Panel Vote for Obesity Drug
5/14/2012
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Gilead Sciences, Inc. (GILD)'s Pill Wins U.S. Panel Backing to Prevent HIV
5/11/2012
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Talon Therapeutics, Inc. (TLON.OB) Receives Notification of Three Month PDUFA Date Extension for Marqibo(R)
5/8/2012
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Napo Pharmaceuticals, Inc. Comments on FDA Announcing Extension of Crofelemer NDA Priority Review
5/4/2012
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Navidea Biopharmaceuticals (NEOP) Release: FDA Extends PDUFA Date for Lymphoseek® by Three
4/3/2012
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Talon Therapeutics, Inc. (HNAB)' Marqibo(R) Wins Backing of FDA Advisory Panel
3/23/2012
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Napo Pharmaceuticals, Inc. Release: FDA Grants PDUFA Date of June 5, 2012 for Crofelemer
2/8/2012
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Talon Therapeutics, Inc. (HNAB)' Product Candidate Marqibo(R) to be Assessed by Oncologic Drug Advisory Committee (ODAC) on March 21, 2012 With a PDUFA Date of May 13, 2012
2/3/2012
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Alexza Pharmaceuticals, Inc. (ALXA) Announces Extension of the ADASUVE™ PDUFA Goal Date by Three Months
1/23/2012
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FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics, Inc. (CTIC)' Resubmitted Pixantrone New Drug Application
12/6/2011
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FDA Extends Protalix Biotherapeutics, Inc. (PLX)'s Taliglucerase Alfa PDUFA Date to May 1, 2012
12/6/2011
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FDA Delays Review of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
11/18/2011
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QRxPharma Pty Ltd. Granted Target Date for FDA Action on MoxDuo® IR NDA: NDA Accepted for Review; PDUFA Date Set for June 25, 2012
11/8/2011
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FDA Revises IntelGenx Corp.' CPI-300 PDUFA Date to November 10th
11/7/2011
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Takeda Global Research & Development Center, Inc. Announces PDUFA Action Date for Investigational Type 2 Diabetes Therapies Alogliptin and the Fixed-Dose Combination Alogliptin/Pioglitazone
11/1/2011
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FDA Delays Ruling on Bristol-Myers Squibb Company (BMY), AstraZeneca PLC (AZN) Diabetes Drug
10/28/2011
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Biogen Idec, Inc. (Massachusetts) (BIIB) and Elan Corporation PLC (ELN) Receive Notification of PDUFA Date Extension
10/20/2011
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Transcept Pharmaceuticals, Inc. (TSPT) Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011
10/5/2011
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Discovery Laboratories (DSCO) Notified of PDUFA Date for SURFAXIN(R)
9/28/2011
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Amgen (AMGN): FDA to Decide on New Xgeva Use by April
8/26/2011
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Alexza Pharmaceuticals, Inc. (ALXA) Announces Adasuve (Staccato(R) Loxapine) PDUFA Goal Date of February 4, 2012
8/19/2011
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Affymax, Inc. (AFFY) Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application
8/11/2011
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA
8/1/2011
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IntelGenx Corp. Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet
6/14/2011
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FDA Delays Decision on Pacira Pharmaceuticals, Inc.'s Exparelf
6/14/2011
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Lannett Company, Inc. (LCI) Announces Revised FDA PDUFA Date for Morphine Sulfate Oral Solution NDA
6/7/2011
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Labeling and Script Use May Cause Problems For Optimer Pharmaceuticals, Inc. (OPTR)'s New Drug
5/27/2011
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INSYS Therapeutics Announces NDA PDUFA Date for Fentanyl SL Spray
5/23/2011
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Seattle Genetics, Inc. (SGEN) Announces FDA Accepts Brentuximab Vedotin BLA; PDUFA Date Set for August 30, 2011
5/2/2011
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Optimer Pharmaceuticals, Inc. (OPTR) Wins FDA Advisory Panel's Backing for Fidaxomicin for Treatment of Patients With Clostridium difficile Infection (CDI)
4/7/2011
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FDA Accepts for Review Spectrum Pharmaceuticals, Inc. (SPPI)’s ZEVALIN(R) Submission for the Removal of the Bioscan; Spectrum Establishes PDUFA Date
3/22/2011
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FDA Assigns PDUFA Date for Shire plc's FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
3/21/2011
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US FDA Assigns New PDUFA Date for AstraZeneca PLC (AZN)'s BRILINTA (ticagrelor tablets)
2/4/2011
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Transcept Pharmaceuticals, Inc. (TSPT) Announces Intermezzo(R) PDUFA Action Date of July 14, 2011
1/31/2011
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DURECT Corporation (DRRX), King Pharmaceuticals®, Inc.'s REMOXY(R) New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011
1/27/2011
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ADVENTRX Pharmaceuticals Inc. (ANX) Receives PDUFA Date for Exelbine NDA
1/19/2011
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KV Pharmaceutical Company (KV-A) Updates Status of New Drug Application for Gestiva(TM); FDA Extends PDUFA Date to April 13, 2011
1/12/2011
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FDA Delays PDUFA On Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline (GSK) Lupus Drug Benlysta
12/7/2010
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FDA Accepts for Review Spectrum Pharmaceuticals, Inc. (SPPI)’s Response on FUSILEV(R) as a Class 2 Submission, and Establishes April 29, 2011 as PDUFA Action Date
11/29/2010
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Salix Pharmaceuticals, Ltd. (SLXP) Says FDA Extends Review of Bowel Syndrome Drug; PDUFA Goal Date Extended by 3 Months
10/4/2010
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Endo Pharmaceuticals (ENDP) Receives FDA Priority Review for New Formulation of Long-Acting Oxymorphone Designed to be Crush Resistant; PDUFA Date Set for January 7
9/22/2010
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Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Says FDA To Take More Time To Review Label Wording for Acthar
9/9/2010
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GlaxoSmithKline (GSK), Valeant Pharmaceuticals International (VRX) Face US Delay for Epilepsy Drug, Receives New PDUFA Date
8/31/2010
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FDA Panel To Vet Boehringer Ingelheim Corporation Blood Thinner September 20
8/26/2010
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Cumberland Pharmaceuticals (CPIX) Announces Extension of FDA Review of Acetadote(R) Supplemental New Drug Application; New PDUFA Date in December 2010
8/23/2010
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Arena Pharmaceuticals, Inc. (ARNA)'s Weight-loss Medication Lorcaserin Comparable to Orlistat or Sibutramine, Florida Hospital in Winter Park Study
8/6/2010
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Warner Chilcott, PLC (WCRX) Announces 3-Month Extension of PDUFA Date on Next Generation Actonel Product
7/16/2010
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Protalix Biotherapeutics Receives PDUFA Date For Taliglucerase Alfa; May Not Rule Until 2011
7/12/2010
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Orexigen Therapeutics, Inc. (OREX) Announces Assignment of January 31, 2011 PDUFA Date for Contrave(R) New Drug Application
6/17/2010
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Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Receives Notification of PDUFA Date Extension to September 11, 2010
6/14/2010
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AVANIR Pharmaceuticals (AVNR) Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010
5/17/2010
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FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq
5/11/2010
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Amylin Pharmaceuticals, Inc. (AMLN), Alkermes plc (ALKS), Eli Lilly and Company (LLY) BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010
5/6/2010
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS) Submit Reply to FDA Complete Response Letter for BYDUREON(TM); FDA to Issue New PDUFA Target Date
4/23/2010
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FDA Panel to Review VIVUS, Inc. (VVUS) Anti-Obesity Drug QNEXA on July 15, 2010
3/26/2010
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) Diabetes Drug Faces Crucial FDA Decision
3/10/2010
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ISTA Pharmaceuticals, Inc. (ISTA) Receives PDUFA Action Date of October 16, 2010 for FDA Review of Once-Daily XiDay(TM)
3/9/2010
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NicOx SA (NCOX.F) Announces FDA Advisory Committee to Discuss Naproxcinod on May 12; PDUFA Date Set for July 24, 2010
3/8/2010
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Arena Pharmaceuticals, Inc. (ARNA) Receives PDUFA Date for Lorcaserin NDA
2/26/2010
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Amylin Pharmaceuticals, Inc. (AMLN)'s (JOBS) Exenatide Once Weekly New Drug Application Review Extended By FDA; New PDUFA Action Date March 12
2/25/2010
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FDA Panel to Review Salix Pharmaceuticals, Ltd. (SLXP) NDA for Xifaxan; NASDAQ Halts Trading in SLXP Stock
2/23/2010
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US FDA to Decide on Amgen (AMGN) (JOBS) Osteoporosis Drug, PDUFA Action Date Set to July 25, 2010
2/22/2010
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Javelin Pharmaceuticals (JAV)' Receives FDA PDUFA Date for Dyloject NDA
2/17/2010
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CombinatoRx, Incorporated (CRXX) Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010
2/17/2010
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Alexza Pharmaceuticals, Inc. (ALXA) Announces AZ-004 (Staccato(R) Loxapine) PDUFA Goal Date of October 11, 2010
2/11/2010
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XenoPort, Inc. (XNPT) Announces Extension of the Horizant PDUFA Date to February 11, 2010
2/10/2010
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XenoPort, Inc. (XNPT) Announces Horizant(TM) as Brand Name for XP13512
2/4/2010
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FDA Extends Sepracor, Inc. (SEPR) PDUFA Action Date for STEDESA; New Drug Application to April 30, 2010
1/28/2010
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Theratechnologies Inc. (TH.TO) Says FDA Delays Fat Drug Review Date
1/26/2010
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Theratechnologies Inc. (TH.TO) Reports Date for FDA Advisory Committee Review of the Tesamorelin New Drug Application
1/19/2010
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Dendreon Corporation (DNDN) (JOBS) Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010
11/20/2009
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GlaxoSmithKline (GSK) (JOBS) and XenoPort, Inc. (XNPT) Announce Extension of GSK1838262 (XP13512) FDA Review Date to February 9, 2010
11/10/2009
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FDA Grants Priority Review for Shire plc's Velaglucerase Alfa for Type 1 Gaucher Disease; PDUFA Date is February 28, 2010
11/4/2009
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Acorda Therapeutics (ACOR) (JOBS) Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
10/23/2009
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New PDUFA Action Date Assigned for Labopharm (DDS.TO) Drug; FDA Could Rule in February
8/26/2009
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NeurogesX, Inc. (JOBS) Announces New PDUFA Date for Qutenza(TM) New Drug Application
8/7/2009
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NeurogesX, Inc. (JOBS) Announces Preliminary Results of FDA-Requested Qutenza(TM) Study; PDUFA Date of August 16, 2009
7/24/2009
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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
7/20/2009
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AMAG Pharmaceuticals, Inc. (AMAG) Expects FDA Action on Anemia Drug Within Days
7/1/2009
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U.S. FDA Panel Urges Approval of Savient Pharmaceuticals, Inc. (SVNT) Gout Drug; PDUFA Action Date is August 1, 2009
6/18/2009
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Dyax Corp. (DYAX) Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema
6/8/2009
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AMAG Pharmaceuticals, Inc. Announces New PDUFA Date for Feraheme (ferumoxytol injection)
5/13/2009
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AstraZeneca PLC (AZN) and Bristol-Myers Squibb Company (BMY) Diabetes Drug Onglyza Faces FDA Delay; PDUFA Extended to July 30
4/23/2009
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PPD, Inc. (PPDI) Updates Discovery Segment Guidance Regarding Alogliptin; PDUFA Date Remains Unchanged
3/6/2009
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FDA Provides PDUFA Target Agency Action Date For GTx, Inc. (GTXI)'s Toremifene 80 mg NDA
3/5/2009
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FDA Accepts Nuvo Research Inc. (NRI.TO)'s Resubmission For Pennsaid(R)
2/19/2009
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Zogenix, Inc. Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM) - Potential Final Approval July 2009
2/18/2009
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FDA Accepts Eurand's Response to Approvable Letter for EUR-1008 as Complete
1/29/2009
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Review of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Febuxostat New Drug Application Continues Past PDUFA Date
1/20/2009
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Ipsen: FDA’s First-Cycle Review of Reloxin(R) Extended
1/7/2009
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Spectrum Pharmaceuticals, Inc. (SPPI) Announces ZEVALIN sBLA Granted Priority Review by the FDA; Target Decision (PDUFA) Date of April 2, 2009
12/1/2008
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BioDelivery Sciences International (BDSI) Remains on Schedule for December ONSOLIS Resubmission Following Meeting with FDA
11/19/2008
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Salix Pharmaceuticals, Ltd. (SLXP) Release: FDA Extends METOZOLV(TM) ODT Review Date
11/18/2008
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Genzyme Corporation (GENZ) Release: Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval
11/17/2008
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FDA Panel Mixed on King Pharmaceuticals®, Inc., Pain Therapeutics (PTIE) Drug; FDA Scheduled to Act By December 10 Under Six-Month Priority Review
11/14/2008
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AMAG Pharmaceuticals, Inc. (AMAG) Says FDA Accepts Anemia Drug Response; Shares Soar in Pre-Market Trade; FDA Establishes December 30, 2008 PDUFA Action Date
11/13/2008
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FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Laboratories (DSCO)' Surfaxin
11/10/2008
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KV Pharmaceutical Company (KV-A) Provides Update on Gestiva(TM) PDUFA Date
10/21/2008
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Forest Laboratories, Inc. (FRX) (JOBS), Cypress Bioscience Inc. (CYPB) Fibromyalgia Drug Delayed at FDA
10/20/2008
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE) (JOBS) Says U.S. Delays Ulcer Drug Decision
10/20/2008
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Life Science Weekly inSite (Oct. 6 - 10)
10/13/2008
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FDA Will Not Be Able To Complete Its Review Of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s (JOBS) Alogliptin (SYR-322) NDA By The Prescription Drug User Fee Act (PDUFA) Date Of October 27, 2008; Delay Puts PPD, Inc. (PPDI) Payment On Hold
10/10/2008
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Ipsen: FDA's First-Cycle Review of Dysport(R) to Be Completed by Year-End
9/30/2008
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NovaDel Pharma (NVD) Announces PDUFA Deadline Extension on Zolpimist(TM)
9/19/2008
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EPIX Pharmaceuticals, Inc. (EPIX) to Regain Full Worldwide Commercial Rights For Vasovist(R); PDUFA Date Remains Unchanged
9/4/2008
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KV Pharmaceutical Company (KV-A) Expects October Due Date for Preterm Labor Drug Approval
9/2/2008
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CV Therapeutics, Inc. (CVTX) (JOBS) Says FDA Continues to Review Ranexa(R) Applications Beyond PDUFA Action Date
7/28/2008
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FDA to Rule on Labopharm (DDS.TO)'s Tramadol by January
7/17/2008
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Labopharm (DDS.TO) Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol
7/3/2008
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FDA Panel To Discuss Roche Holding AG (RHHBF.PK) Arthritis Drug July 29
6/5/2008
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Eli Lilly and Company (LLY) Nears FDA Decision On Key Cardio Drug Prasugrel
6/5/2008
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Indevus Pharmaceuticals, Inc. (IDEV) Expects FDA to Request Additional Safety Study of NEBIDO Prior to Approval
6/4/2008
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FDA Decision on Amgen (AMGN) Clotting Drug Delayed
4/9/2008
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FDA Surprise Might Spark Genentech, Inc. (DNA)
2/6/2008
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Skyepharma PLC (SKYE) Announces Research Update; FDA Extends Review Period for Requip(R)
2/5/2008
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CV Therapeutics, Inc. (CVTX): FDA to Review Additional Use of Angina Drug
12/7/2007
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Spectrum Pharmaceuticals, Inc. (SPPI) Says FDA Extends Action Date for New Drug Review
11/21/2007
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Biovail Corporation (BVF) Stock Down after FDA Drug Classification
11/20/2007
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Sciele Pharma, Inc. (SCRX) Reports That FDA Extends PDUFA Date on New Sular Formulation to January 2, 2008
11/5/2007
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Skyepharma PLC (SKYE) Announces Product Update
11/5/2007
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Solvay Pharmaceuticals, Inc. Announces FDA Extension of Tedisamil PDUFA Date
9/26/2007
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FDA Accepts New Drug Application for Priority Review of Tibotec Pharmaceuticals Ltd Investigational HIV Treatment TMC125
9/20/2007
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Sciele Pharma, Inc. (SCRX) Announces Acceptance by FDA of sNDA for New Sular Formulation
9/4/2007
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Cardiome Pharma Corp. (COM.TO) (Jobs) and Astellas Pharma US, Inc. (Jobs) Announce PDUFA Action Date Extended by Three Months
8/30/2007
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Adolor Corporation (ADLR) and GlaxoSmithKline (GSK) Say FDA Accepts for Review Complete Response to Approvable Letter for Entereg(R) (alvimopan) for POI; PDUFA February 10, 2008
8/28/2007
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Neurocrine Biosciences, Inc. (NBIX) Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules
8/22/2007
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DOR BioPharma, Inc. (DORB) Announces 3 Month Extension of FDA PDUFA Action Date for orBec(R) New Drug Application to Review Supplemental Data
7/19/2007
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An Investor's Guide to the New PDUFA
7/18/2007
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Merck & Co., Inc. (MRK) Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL(R)
6/21/2007
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FDA Accepts Spectrum Pharmaceuticals, Inc. (SPPI)'s Satraplatin NDA And Grants Priority Review
4/16/2007
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Neurochem, Inc. (NRMX)'s Eprodisate (KIACTA(TM)) PDUFA Date Extended Three Months by FDA
4/11/2007
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Someone's Betting On Dendreon Corporation (DNDN)
4/10/2007
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IDM Pharma, Inc. (IDMI) Announces Oncologic Drugs Advisory Committee Meeting for Junovan(TM) (Mifamurtide) Will Take Place on May 9, 2007
4/3/2007
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Dendreon Corporation (DNDN) Shares Halted Ahead of FDA Meeting
3/29/2007
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FDA: Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
3/27/2007
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Endo Pharmaceuticals (ENDP) and Vernalis PLC (VNLS) Announce Three-Month Extension of PDUFA Date for Frova(R) sNDA
3/16/2007
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FDA to Review Arcoxia, Merck & Co., Inc. (MRK)'s (Jobs) Follow-Up to Vioxx
3/5/2007
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Pro-Pharmaceuticals, Inc. (PRW) Meeting Scheduled With The FDA; April 11th Meeting To Discuss NDA Submission For Co-administration Of DAVANAT(R) With 5-FU To Treat Cancer Patients
2/23/2007
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FDA Panel To Review Pfizer Inc. (PFE) (Jobs) HIV Drug
2/8/2007
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FDA Advisory Committee To Review DOR BioPharma, Inc. (DORB)'s orBec(R) For The Treatment Of GI GVHD
1/31/2007
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Cipher Pharmaceuticals (DND.TO)'s Response To Approvable Letter For CIP-ISOTRETINOIN Accepted For Review By FDA
1/17/2007
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FDA Accepts Encysive Pharmaceuticals (ENCY)' Complete Response To Thelin New Drug Application
12/28/2006
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Labopharm (DDS.TO) Submits Response To Approvable Letter For Once-Daily Tramadol To FDA
12/20/2006
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Genta Incorporated (GNTA) Announces FDA's Oncology Drug Advisory Committee Will Review Genasense(R) As Treatment For Chronic Lymphocytic Leukemia
7/27/2006
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Adeza Biomedical (ADZA) Announces August 29 FDA Advisory Committee Date To Review Gestiva To Prevent Preterm Births
7/18/2006
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Nastech Pharmaceutical Company Inc. (NSTK) Receives FDA Communication Concerning Calcitonin-Salmon Nasal Spray; FDA Rejects Generic Version Of Miacalcin
7/13/2006
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Bradley Pharmaceuticals (BDY) Release: FDA Extends PDUFA Date For Polyphenon(R) E Ointment To October 31, 2006
6/30/2006
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Oscient Pharmaceuticals Corporation (OSCI) Announces Meeting Date For FDA Advisory Committee To Address sNDA For Five-Day Treatment Of Acute Bacterial Sinusitis With FACTIVE Tablets
6/28/2006
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Salix Pharmaceuticals, Ltd. (SLXP) MoviPrep(R) FDA Action Date Established; PDUFA Is August 2, 2006
6/21/2006
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AVANIR Pharmaceuticals (AVNR) Says FDA Delays Drug Review By 90 Days; PDUFA Is October 30, 2006
6/20/2006
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FDA Grants Class 1 Review To Encysive Pharmaceuticals (ENCY)' Complete Response To Thelin(TM) (Sitaxsentan Sodium) New Drug Application; PDUFA Is July 24, 2006
6/15/2006
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MGI PHARMA, INC. (MOGN) Release: Saforis (TM) NDA Accepted By U.S. FDA For Priority Review; PDUFA Is October 12, 2006
6/13/2006
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ZOLINZA(TM), Merck & Co., Inc. (MRK)'s Investigational Medicine For Advanced Cutaneous T-Cell Lymphoma (CTCL), To Receive Priority Review From U.S. FDA
6/8/2006
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Sepracor, Inc. (SEPR) Presents Positive Arformoterol Data; Shares Soar; PDUFA Is October 12, 2006.
5/25/2006
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