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Clinical - PDUFA
FDA Acknowledges Receipt Of Sorrento (SRNE), NDA For ZTlido; PDUFA Date Set For February 28, 2018 9/12/2017
7 PDUFA Dates to Mark on Your Calendars for September 9/7/2017
Revisiting Neos Therapeutics (NEOS) Before Key FDA Date 8/28/2017
Advanced Accelerator Applications Announces New Prescription Drug User Fee Act (PDUFA) Date Of January 26, 2018, For Lutetium Lu 177 Dotatate (Lutathera) 8/28/2017
Should You Buy Adamas Pharma (ADMS) Stock Ahead Of Upcoming PDUFA On August 24? 8/14/2017
Lipocine (LPCN) Announces FDA Acknowledgement Of TLANDO (“LPCN 1021”) NDA Resubmission; PDUFA Goal Date, February 8, 2018 8/14/2017
Gilead (GILD)'s HIV Triple Combo Gets Sped-up FDA Review, Decision Date Locked Down 8/11/2017
A Biotech Binary Event Playbook: How To Play Clovis Oncology (CLVS) And Tesaro (TSRO) Ahead Of Label Decision 8/9/2017
Dynavax (DVAX) Shares Plunge on Delayed FDA Decision for Hep B Vaccine Heplisav 8/4/2017
Highland Therapeutics’ ADHD Drug Hit With Delay, Company Still in Discussions With FDA 8/3/2017
8 PDUFA Dates to Watch in August 8/2/2017
Eagle Pharma (EGRX) Issues Statement Regarding RYANODEX Application PDUFA Date For Exertional Heat Stroke 7/25/2017
Adamas Pharma (ADMS) Presents Expanded Analysis From The ADS-5102 Open-Label Study Showing Tolerability And Durability Out To 88 Weeks 6/9/2017
Little-Known Emmaus Life Sciences Wins FDA Panel Backing for Sickle Cell Disease Med 5/25/2017
Intersect ENT Announces PDUFA Date For Office-Based SINUVA Steroid Releasing Sinus Implant 5/22/2017
Bay Area's Intersect ENT Gets a PDUFA Date From the FDA for Steroid Releasing Sinus Implant 5/22/2017
Ocular Therapeutix (OCUL) Presented Phase III Data For DEXTENZA At Association for Research in Vision & Ophthalmology Annual Meeting 5/11/2017
Bausch & Lomb Announces PDUFA Date For New OTC Redness Reliever, Brimonidine Tartrate Ophthalmic Solution, 0.025% 5/9/2017
4 Biotechs That Could Explode Or Crash In May 5/5/2017
NicOx SA (COX.PA) Announces PDUFA Date For ZERVIATE NDA 4/11/2017
Bausch & Lomb And NicOx SA (COX.PA) Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene Bunod 3/21/2017
Radius Health (RDUS) Falls on PDUFA Extension for Abaloparatide-SC 3/10/2017
AcelRx (ACRX)' New Drug Application For DSUVIA Accepted For Filing With PDUFA Date Of October 12, 2017 2/27/2017
FDA Informs Portola (PTLA) At Mid-Cycle Review For Betrixaban That It Has Not Identified Issues That Require An Advisory Committee Meeting 2/8/2017
6 Biopharma Companies Face Catalysts in February 1/31/2017
7 Biotech Companies With Key FDA Decisions or Catalysts in January and February 2017 1/3/2017
Tris Pharma, Inc. Release: FDA Accepts CCP-08 NDA For Full Review 12/21/2016
Emmaus Life Sciences Receives Notice Of FDA PDUFA Date For Investigational L-Glutamine Treatment For Sickle Cell Disease 11/29/2016
The FDA Won't Meet PDUFA Goal Date For Egalet's ARYMO ER 10/14/2016
Lexicon Pharma (LXRX) Release: FDA Extends PDUFA Date For Telotristat Etiprate For The Treatment Of Carcinoid Syndrome 9/15/2016
Vernalis PLC (VNLPY.PK) Release: FDA Accepts CCP-07 NDA For Full Review 9/6/2016
Amid Trial Concerns, FDA Delays Approval Decision for Merck & Co. (MRK)'s C. Diff Drug, New PDUFA Date Set 7/22/2016
DURECT (DRRX)’s PDUFA Date for Remoxy NDA of Sept 25 Unchanged 7/1/2016
FDA Advisory Committee Meeting on August 4 for Egalet’s ARYMO; PDUFA Date is October 14 6/28/2016
Advanced Accelerator Applications Announces FDA Priority Review for Lutathera; PDUFA Target Action Date is December 28, 2016 6/27/2016
2 Biotechs Investors Should Pick Up Before Key PDUFA Dates 5/5/2016
FDA Pushes Back PDUFA Date for Dynavax (DVAX)'s Hep B Vaccine HEPLISAV-B 4/27/2016
FDA Extends Action Date for Progenics (PGNX), Valeant (VRX)'s NDA for Oral RELISTOR 4/4/2016
Dynavax (DVAX) Announces FDA Acceptance For Review Of Biologics License Application And PDUFA Action Date For HEPLISAV-B 3/31/2016
Three Biotechs Cited as Promising Bets in 2016 With FDA Decisions Pending 2/22/2016
FDA Delays Decision on Sarepta (SRPT)'s Muscle-Wasting Disorder Drug 2/9/2016
Akashi Halts DMD Clinical Trial, Third Company to Recently Have Problems With DMD Drug Trials 1/26/2016
With Snowmageddon Predicted for East Coast, FDA Postpones Meeting Over Sarepta (SRPT)’s DMD Drug 1/21/2016
FDA Delays Decision of Bay Area-Based Heron (HRTX)'s Nausea Drug Sustol 1/15/2016
FDA Review of Clovis Oncology (CLVS)'s Lung Cancer Therapy Extended by Three Months 12/16/2015
Medicure Inc. (MCU) Announces PDUFA Action Date For New Aggrastat Indication 12/2/2015
Lipocine Inc. (LPCN) Announces PDUFA Goal Date For LPCN 1021 NDA 11/13/2015
Acadia (ACAD) Announces FDA Priority Review Of NUPLAZID (Pimavanserin) New Drug Application For Parkinson’s Disease Psychosis 11/2/2015
Collegium (COLL) Falls in Aftermarket Trading After FDA Delays Ruling on Opiod Painkiller 10/13/2015
FDA Delays Decision on Alexion (ALXN)'s Lead Drug Kanuma by Three Months 9/4/2015
Alexion (ALXN) Receives Notification Of PDUFA Date Extension For Kanuma (Sebelipase Alfa) 9/4/2015
Repros Therapeutics Inc. (RPRX) Announces November 30, 2015 PDUFA Goal Date For New Drug Application 4/16/2015
Pfizer (PFE) Provides Update On IBRANCE® (Palbociclib) 1/8/2015
Relypsa, Inc. (RLYP) Announces Assignment Of October 21, 2015 PDUFA Date For New Drug Application For Patiromer For Oral Suspension 1/5/2015
Pharmacyclics, Inc. (PCYC) Announces Update On IMBRUVICA® (Ibrutinib) Waldenstrom's Macroglobulinemia (WM) Submission 12/22/2014
FDA Postpones Its Final Decision On NPS Pharmaceuticals, Inc. (NPSP)'s Natpara 10/24/2014
FDA Delays Decision On IMPAX Laboratories, Inc. (IPXL) Parkinson's Drug RYTARY 9/18/2014
AcelRx Pharmaceuticals (ACRX) Confirms July 27, 2014 PDUFA Date For Zalviso 7/25/2014
Flamel Technologies (FLML) Receives Class 1 Response Designation For Second NDA 6/16/2014
Orexigen Therapeutics, Inc. (OREX)'s Much Anticipated Weight Loss Drug NB32 Gets New PDUFA Date From The FDA 6/11/2014
NPS Pharmaceuticals, Inc. (NPSP) Reports Change In Tentative Date Of FDA Advisory Committee Review Of Natpara® BLA To September 12 - PDUFA Date Of October 24 Remains Unchanged 6/10/2014
Orexigen Therapeutics, Inc. (OREX) Announces June 11, 2014 PDUFA Action Date For NB32 6/2/2014
Keryx Biopharmaceuticals (KERX) Receives Notification Of PDUFA Date Extension For Zerenex™ 5/23/2014
Baxter International, Inc. (BAX) Provides U.S. Regulatory Update On Hyqvia, Its Investigational Subcutaneous Treatment For Primary Immunodeficiency 5/21/2014
Alimera Sciences (ALIM) Announces New PDUFA Date For ILUVIEN® 4/14/2014
MannKind Corporation (MNKD) Drops As The FDA Delays Decision On Inhaled Insulin Treatment 4/7/2014
Andarix Receives Orphan Drug Deisgnation From FDA For Small Cell Lung Cancer 3/26/2014
Biogen Idec, Inc. (Massachusetts) (BIIB) Receives Notification Of PDUFA Date Extension For Plegridy™ (Peginterferon Beta-1a) 3/18/2014
Salix Pharmaceuticals, Ltd. (SLXP), Pharming Group (PHGUF.PK) Announce Extension Of PDUFA Action Date For RUCONEST® 2/24/2014
Nervous Chelsea Therapeutics, Inc. (CHTP) Still Awaiting News From The FDA On NORTHERA™ 2/18/2014
FDA Delays Trimel BioPharma's CompleoTRT™ PDUFA Date 1/17/2014
FDA Accepts New Drug Application For Gilead Sciences, Inc. (GILD)'s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin's Lymphoma 1/13/2014
Orexigen Therapeutics, Inc. (OREX) Announces June 10, 2014 PDUFA Action Date For Contrave 1/7/2014
Pozen, Inc. (POZN) Announces New PA8140/PA32540 PDUFA Date Of April 25, 2014 12/23/2013
QRxPharma Pty Ltd. Announces 25 May 2014 As New PDUFA Date For MOXDUO® NDA 12/11/2013
FDA Extends Review Of Biogen Idec, Inc. (Massachusetts) (BIIB)'s Hemophilia Drug ALPROLIX™ 12/2/2013
Biogen Idec, Inc. (Massachusetts) (BIIB), Swedish Orphan Biovitrum Hemophilia Drug Delayed As FDA Seeks More Info 11/13/2013
Keryx Biopharmaceuticals (KERX) Announces PDUFA Goal Date for Zerenex™ New Drug Application 10/21/2013
Investors Cheerful at FDA's Decision to Extend Deadline for AMAG Pharmaceuticals, Inc. (AMAG)'s Feraheme®; Stock Up 5.89% at Market Close (October 17, 2013) 10/17/2013
Auxilium Pharmaceuticals (AUXL) Receives Notification of XIAFLEX® PDUFA Extension 8/28/2013
GlaxoSmithKline (GSK) Diabetes Drug Faces U.S. Approval Delay 8/2/2013
FDA Accepts DURECT Corporation (DRRX)'s NDA for POSIDUR 6/20/2013
German Regulator Rebuffs Sanofi (France) (SAN.PA) Diabetes Drug 6/19/2013
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
Alimera Sciences (ALIM) Announces New PDUFA Date for ILUVIEN® 5/1/2013
QRxPharma Pty Ltd. Sets PDUFA Date for MOXDUO® NDA 3/14/2013
Hyperion Therapeutics Notified That FDA Will Not Meet the PDUFA Action Date for Ravicti™ 1/16/2013
Pfizer Inc. (PFE)/Ligand Pharmaceuticals Inc. (LGND) Get PDUFA Date for Menopause Combo 12/14/2012
Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug 10/19/2012
FDA Extends Review of Biogen Idec, Inc. (Massachusetts) (BIIB) MS Drug 10/18/2012
A.P. Pharma, Inc. (APPA) Announces PDUFA Action Date for APF530 New Drug Application Resubmission 10/16/2012
Impax Pharmaceuticals (IPXL): FDA Extends Review on Rytary NDA 10/12/2012
GlaxoSmithKline (GSK), Theravance, Inc. (THRX): FDA OK for FF/VI 9/27/2012
Hyperion Therapeutics Announces Extension of Action Date for Ravicti™ NDA to January 23, 2013 9/6/2012
Medivation, Inc. (MDVN) and Astellas Pharma Inc. (YPH.BE) Get PDUFA Date for Prostate Cancer Drug 8/6/2012
FDA Grants Priority Review for Exelixis, Inc. (EXEL)'s Cabozantinib in Medullary Thyroid Cancer 7/30/2012
Alexza Pharmaceuticals, Inc. (ALXA) Announces Adasuve PDUFA Goal Date Of Dec. 21, 2012 7/6/2012
Consumer Group Urges FDA to Reject Arena Pharmaceuticals, Inc. (ARNA) Diet Drug 6/28/2012
Eli Lilly and Company (LLY) Statement on PDUFA Vote by Senate 6/27/2012
If Arena Pharmaceuticals, Inc. (ARNA)'s Lorcaserin is Approved, Buy VIVUS, Inc. (VVUS) 6/27/2012
FDA Receives Repros Therapeutics Inc. (RPRX)' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal(R) 5/17/2012
Arena Pharmaceuticals, Inc. (ARNA) Wins Positive FDA Panel Vote for Obesity Drug 5/14/2012
Gilead Sciences, Inc. (GILD)'s Pill Wins U.S. Panel Backing to Prevent HIV 5/11/2012
Talon Therapeutics, Inc. (TLON.OB) Receives Notification of Three Month PDUFA Date Extension for Marqibo(R) 5/8/2012
Napo Pharmaceuticals, Inc. Comments on FDA Announcing Extension of Crofelemer NDA Priority Review 5/4/2012
Navidea Biopharmaceuticals (NEOP) Release: FDA Extends PDUFA Date for Lymphoseek® by Three 4/3/2012
Talon Therapeutics, Inc. (HNAB)' Marqibo(R) Wins Backing of FDA Advisory Panel 3/23/2012
Napo Pharmaceuticals, Inc. Release: FDA Grants PDUFA Date of June 5, 2012 for Crofelemer 2/8/2012
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
Alexza Pharmaceuticals, Inc. (ALXA) Announces Extension of the ADASUVE™ PDUFA Goal Date by Three Months 1/23/2012
FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics, Inc. (CTIC)' Resubmitted Pixantrone New Drug Application 12/6/2011
FDA Extends Protalix Biotherapeutics, Inc. (PLX)'s Taliglucerase Alfa PDUFA Date to May 1, 2012 12/6/2011
FDA Delays Review of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone 11/18/2011
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
FDA Revises IntelGenx Corp.' CPI-300 PDUFA Date to November 10th 11/7/2011
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
FDA Delays Ruling on Bristol-Myers Squibb Company (BMY), AstraZeneca PLC (AZN) Diabetes Drug 10/28/2011
Biogen Idec, Inc. (Massachusetts) (BIIB) and Elan Corporation PLC (ELN) Receive Notification of PDUFA Date Extension 10/20/2011
Transcept Pharmaceuticals, Inc. (TSPT) Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011 10/5/2011
Discovery Laboratories (DSCO) Notified of PDUFA Date for SURFAXIN(R) 9/28/2011
Amgen (AMGN): FDA to Decide on New Xgeva Use by April 8/26/2011
Alexza Pharmaceuticals, Inc. (ALXA) Announces Adasuve (Staccato(R) Loxapine) PDUFA Goal Date of February 4, 2012 8/19/2011
Affymax, Inc. (AFFY) Announces Assignment of March 27, 2012 PDUFA Date for Peginesatide New Drug Application 8/11/2011
Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS)'s BYDUREON Reply Submitted to FDA 8/1/2011
IntelGenx Corp. Announces New PDUFA Date for Its Single Dose 450 mg Bupropion Hydrochloride Tablet 6/14/2011
FDA Delays Decision on Pacira Pharmaceuticals, Inc.'s Exparelf 6/14/2011
Lannett Company, Inc. (LCI) Announces Revised FDA PDUFA Date for Morphine Sulfate Oral Solution NDA 6/7/2011
Labeling and Script Use May Cause Problems For Optimer Pharmaceuticals, Inc. (OPTR)'s New Drug 5/27/2011
INSYS Therapeutics Announces NDA PDUFA Date for Fentanyl SL Spray 5/23/2011
Seattle Genetics, Inc. (SGEN) Announces FDA Accepts Brentuximab Vedotin BLA; PDUFA Date Set for August 30, 2011 5/2/2011
Optimer Pharmaceuticals, Inc. (OPTR) Wins FDA Advisory Panel's Backing for Fidaxomicin for Treatment of Patients With Clostridium difficile Infection (CDI) 4/7/2011
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
FDA Assigns PDUFA Date for Shire plc's FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema 3/21/2011
US FDA Assigns New PDUFA Date for AstraZeneca PLC (AZN)'s BRILINTA (ticagrelor tablets) 2/4/2011
Transcept Pharmaceuticals, Inc. (TSPT) Announces Intermezzo(R) PDUFA Action Date of July 14, 2011 1/31/2011
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
ADVENTRX Pharmaceuticals Inc. (ANX) Receives PDUFA Date for Exelbine NDA 1/19/2011
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
FDA Delays PDUFA On Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline (GSK) Lupus Drug Benlysta 12/7/2010
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
Salix Pharmaceuticals, Ltd. (SLXP) Says FDA Extends Review of Bowel Syndrome Drug; PDUFA Goal Date Extended by 3 Months 10/4/2010
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
Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Says FDA To Take More Time To Review Label Wording for Acthar 9/9/2010
GlaxoSmithKline (GSK), Valeant Pharmaceuticals International (VRX) Face US Delay for Epilepsy Drug, Receives New PDUFA Date 8/31/2010
FDA Panel To Vet Boehringer Ingelheim Corporation Blood Thinner September 20 8/26/2010
Cumberland Pharmaceuticals (CPIX) Announces Extension of FDA Review of Acetadote(R) Supplemental New Drug Application; New PDUFA Date in December 2010 8/23/2010
Arena Pharmaceuticals, Inc. (ARNA)'s Weight-loss Medication Lorcaserin Comparable to Orlistat or Sibutramine, Florida Hospital in Winter Park Study 8/6/2010
Warner Chilcott, PLC (WCRX) Announces 3-Month Extension of PDUFA Date on Next Generation Actonel Product 7/16/2010
Protalix Biotherapeutics Receives PDUFA Date For Taliglucerase Alfa; May Not Rule Until 2011 7/12/2010
Orexigen Therapeutics, Inc. (OREX) Announces Assignment of January 31, 2011 PDUFA Date for Contrave(R) New Drug Application 6/17/2010
Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Receives Notification of PDUFA Date Extension to September 11, 2010 6/14/2010
AVANIR Pharmaceuticals (AVNR) Announces Zenvia Review Timeline Established by FDA with PDUFA Date of October 30, 2010 5/17/2010
FDA Advisory Committee to Review Lux Biosciences' Uveitis Candidate Luveniq 5/11/2010
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
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
FDA Panel to Review VIVUS, Inc. (VVUS) Anti-Obesity Drug QNEXA on July 15, 2010 3/26/2010
Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) Diabetes Drug Faces Crucial FDA Decision 3/10/2010
ISTA Pharmaceuticals, Inc. (ISTA) Receives PDUFA Action Date of October 16, 2010 for FDA Review of Once-Daily XiDay(TM) 3/9/2010
NicOx SA (NCOX.F) Announces FDA Advisory Committee to Discuss Naproxcinod on May 12; PDUFA Date Set for July 24, 2010 3/8/2010
Arena Pharmaceuticals, Inc. (ARNA) Receives PDUFA Date for Lorcaserin NDA 2/26/2010
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
FDA Panel to Review Salix Pharmaceuticals, Ltd. (SLXP) NDA for Xifaxan; NASDAQ Halts Trading in SLXP Stock 2/23/2010
US FDA to Decide on Amgen (AMGN) (JOBS) Osteoporosis Drug, PDUFA Action Date Set to July 25, 2010 2/22/2010
Javelin Pharmaceuticals (JAV)' Receives FDA PDUFA Date for Dyloject NDA 2/17/2010
CombinatoRx, Incorporated (CRXX) Announces Extension of Exalgo Extended-Release Tablets PDUFA Date to March 1, 2010 2/17/2010
Alexza Pharmaceuticals, Inc. (ALXA) Announces AZ-004 (Staccato(R) Loxapine) PDUFA Goal Date of October 11, 2010 2/11/2010
XenoPort, Inc. (XNPT) Announces Extension of the Horizant PDUFA Date to February 11, 2010 2/10/2010
XenoPort, Inc. (XNPT) Announces Horizant(TM) as Brand Name for XP13512 2/4/2010
FDA Extends Sepracor, Inc. (SEPR) PDUFA Action Date for STEDESA; New Drug Application to April 30, 2010 1/28/2010
Theratechnologies Inc. (TH.TO) Says FDA Delays Fat Drug Review Date 1/26/2010
Theratechnologies Inc. (TH.TO) Reports Date for FDA Advisory Committee Review of the Tesamorelin New Drug Application 1/19/2010
Dendreon Corporation (DNDN) (JOBS) Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010 11/20/2009
GlaxoSmithKline (GSK) (JOBS) and XenoPort, Inc. (XNPT) Announce Extension of GSK1838262 (XP13512) FDA Review Date to February 9, 2010 11/10/2009
FDA Grants Priority Review for Shire plc's Velaglucerase Alfa for Type 1 Gaucher Disease; PDUFA Date is February 28, 2010 11/4/2009
Acorda Therapeutics (ACOR) (JOBS) Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010 10/23/2009
New PDUFA Action Date Assigned for Labopharm (DDS.TO) Drug; FDA Could Rule in February 8/26/2009
NeurogesX, Inc. (JOBS) Announces New PDUFA Date for Qutenza(TM) New Drug Application 8/7/2009
NeurogesX, Inc. (JOBS) Announces Preliminary Results of FDA-Requested Qutenza(TM) Study; PDUFA Date of August 16, 2009 7/24/2009
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
AMAG Pharmaceuticals, Inc. (AMAG) Expects FDA Action on Anemia Drug Within Days 7/1/2009
U.S. FDA Panel Urges Approval of Savient Pharmaceuticals, Inc. (SVNT) Gout Drug; PDUFA Action Date is August 1, 2009 6/18/2009
Dyax Corp. (DYAX) Announces FDA Accepts for Review the Complete Response Submission for DX-88 in Hereditary Angioedema 6/8/2009
AMAG Pharmaceuticals, Inc. Announces New PDUFA Date for Feraheme (ferumoxytol injection) 5/13/2009
AstraZeneca PLC (AZN) and Bristol-Myers Squibb Company (BMY) Diabetes Drug Onglyza Faces FDA Delay; PDUFA Extended to July 30 4/23/2009
PPD, Inc. (PPDI) Updates Discovery Segment Guidance Regarding Alogliptin; PDUFA Date Remains Unchanged 3/6/2009
FDA Provides PDUFA Target Agency Action Date For GTx, Inc. (GTXI)'s Toremifene 80 mg NDA 3/5/2009
FDA Accepts Nuvo Research Inc. (NRI.TO)'s Resubmission For Pennsaid(R) 2/19/2009
Zogenix, Inc. Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM) - Potential Final Approval July 2009 2/18/2009
FDA Accepts Eurand's Response to Approvable Letter for EUR-1008 as Complete 1/29/2009
Review of Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Febuxostat New Drug Application Continues Past PDUFA Date 1/20/2009
Ipsen: FDA’s First-Cycle Review of Reloxin(R) Extended 1/7/2009
Spectrum Pharmaceuticals, Inc. (SPPI) Announces ZEVALIN sBLA Granted Priority Review by the FDA; Target Decision (PDUFA) Date of April 2, 2009 12/1/2008
BioDelivery Sciences International (BDSI) Remains on Schedule for December ONSOLIS Resubmission Following Meeting with FDA 11/19/2008
Salix Pharmaceuticals, Ltd. (SLXP) Release: FDA Extends METOZOLV(TM) ODT Review Date 11/18/2008
Genzyme Corporation (GENZ) Release: Myozyme Produced at the 2000 L Bioreactor Scale to Receive Accelerated Approval 11/17/2008
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
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
FDA Establishes Target Action Date of April 17, 2009 for Potential Approval of Discovery Laboratories (DSCO)' Surfaxin 11/10/2008
KV Pharmaceutical Company (KV-A) Provides Update on Gestiva(TM) PDUFA Date 10/21/2008
Forest Laboratories, Inc. (FRX) (JOBS), Cypress Bioscience Inc. (CYPB) Fibromyalgia Drug Delayed at FDA 10/20/2008