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Clinical - Approvable Letter
FDA Accepts for Review Theravance, Inc. (THRX)'s Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections 4/27/2009  More...
Discovery Laboratories (DSCO) to File Surfaxin Response in 4 Weeks 9/24/2008  More...
Cardiome Pharma Corp. (COM.TO) And Astellas Pharma Inc. Announce Receipt Of FDA Approvable Letter For KYNAPID(TM) 8/11/2008  More...
Discovery Laboratories (DSCO) Reports Progress in Responding to Surfaxin FDA Approvable Letter 8/6/2008  More...
UCB Group (UCBJF.PK) Receives Not-approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain 7/30/2008  More...
Eisai Corporation of North America Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures; FDA's Not Approvable Letter Outlines Pathway to Potential Approval 7/28/2008  More...
Vanda Pharmaceuticals, Inc. (VNDA) Announces Receipt of Not Approvable Letter From FDA for Iloperidone 7/28/2008  More...
NexMed (NEXM) Receives FDA Non Approvable Letter for ED Product 7/23/2008  More...
Xanodyne Pharmaceuticals, Inc. Receives Approvable Letter From the U.S. FDA for ZIPSOR(TM) Capsules 7/22/2008  More...
Sciele Pharma, Inc. (SCRX) Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment 7/17/2008  More...
FDA (JOBS) Revises Process for Responding to Drug Applications 7/10/2008  More...
Indevus Pharmaceuticals, Inc. (IDEV) Receives Approvable Letter from FDA for NEBIDO(R); Company Announces Revised Operating Plan to Respond to NEBIDO Delay 6/30/2008  More...
Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) 6/19/2008  More...
Discovery Laboratories (DSCO) Delays Surfaxin Response to FDA 6/19/2008  More...
FDA Requests More Information On Meda AB (SE:MEDAa)'s New Azelastine Formulation 6/4/2008  More...
Wyeth (WYE) Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia 5/29/2008  More...
Discovery Laboratories (DSCO) and FDA to Meet On June 18, 2008 to Clarify Limited Items in SURFAXIN Approvable Letter 5/29/2008  More...
US Delays Approval Of Wyeth (WYE) Osteoporosis Medicine Bazedoxifene 5/23/2008  More...
Discovery Laboratories (DSCO) Provides Guidance on FDA Approvable Letter for Surfaxin for RDS 5/5/2008  More...
US Delays Approval for Discovery Laboratories (DSCO)' Surfaxin 5/2/2008  More...
Merck & Co., Inc. (MRK) Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) 4/29/2008  More...
Schering-Plough Corporation (SGP) and Merck & Co., Inc. (MRK) Receives Not-Approvable Letter from FDA for Loratadine/Montelukast 4/28/2008  More...
Jerini AG Receives Positive CHMP Opinion Recommending European Approval for Icatibant in the Treatment of HAE; FDA Issues Not Approvable Letter 4/25/2008  More...
Johnson and Johnson Pharmaceutical R&D (NJ), Basilea Pharmaceutica Key Drug Fails to Get FDA Approval; Stock Dives 3/18/2008  More...
Astellas Pharma Inc. Sees U.S. Delay on Transplant Drug Advagraf 3/14/2008  More...
Daiichi Sankyo Co Ltd. Says U.S. FDA Rejects Anaemia Drug 3/12/2008  More...
Theravance, Inc. (THRX) Says FDA to Review Response on Antibiotic 3/6/2008  More...
FDA Issues Not-Approvable Letter for Eli Lilly and Company (LLY)'s Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia Treatment 2/28/2008  More...
Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002) 2/28/2008  More...
Jazz Pharmaceuticals, Inc. (JAZZ) Says FDA Accepts Additional Data on Luvox 2/1/2008  More...
Cipher Pharmaceuticals (DND.TO) Receives FDA Response to CIP-TRAMADOL ER Appeal 2/1/2008  More...
IMPAX Laboratories, Inc. (IPXL) Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options 1/30/2008  More...
Merck & Co., Inc. (MRK) Receives Not Approvable Letter from FDA for OTC MEVACOR(R) 20 mg 1/28/2008  More...
FDA Doesn't Overturn Labopharm (DDS.TO)'s Tramadol Ruling 1/24/2008  More...
Wyeth (WYE) Gets Approvable Letter for Osteoporosis Drug 12/26/2007  More...
Pharmacyclics, Inc. (PCYC) Cancer Drug Not Approvable Says US FDA 12/26/2007  More...
Pfizer Inc. (PFE) Receives Approvable Letter from FDA for Dalbavancin 12/26/2007  More...
FDA Issues Approvable Letter for Jazz Pharmaceuticals, Inc. (JAZZ)'s LUVOX(R) CR Extended-Release Capsules for the Treatment of Social Anxiety Disorder and Obsessive Compulsive Disorder 12/26/2007  More...
Indevus Pharmaceuticals, Inc. (IDEV) Gets Non-Approvable Letter for Cancer Therapy 12/20/2007  More...
Neurocrine Biosciences, Inc. (NBIX) Gets FDA Approvable Letter for Indiplon 12/13/2007  More...
FDA Issues Approvable Letter for GlaxoSmithKline (GSK)'s Requip(R) XL (TM) Extended Release Tablets 12/10/2007  More...
Forest Laboratories, Inc. (FRX) and Mylan Laboratories Inc. (MYL) Get FDA Approvable Letter for Nebivolol 12/3/2007  More...
Labopharm (DDS.TO) to Appeal FDA's Tramadol Decision 11/26/2007  More...
Labopharm (DDS.TO) to Appeal FDA's Tramadol Decision 11/21/2007  More...
U.S. Rejects GlaxoSmithKline (GSK)'s Gepirone ER Antidepressant 11/5/2007  More...
Pozen, Inc. (POZN) Announces Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA 11/1/2007  More...
Adams Respiratory Therapeutics Says FDA Seeks More Data to OK Cough Drug 10/29/2007  More...
Noven Pharmaceuticals Inc. (NOVN) Gets FDA Approvable Letter for Stavzor 10/24/2007  More...
FDA Asks for More Information to OK Theravance, Inc. (THRX) Skin Disease Drug 10/22/2007  More...
DOR BioPharma, Inc. (DORB) Receives Not Approvable Letter From FDA for orBec(R) for Treatment of Gastrointestinal Graft-vs.-Host Disease 10/19/2007  More...
Pozen, Inc. (POZN) Submits Response to Approvable Letter for Trexima(TM) 10/15/2007  More...
Labopharm (DDS.TO) Appeals FDA's Tramadol Decision 10/15/2007  More...
Pozen, Inc. (POZN) Plans to Submit Response to Approvable Letter For Trexima(TM) Within the Next Ten Days 10/5/2007  More...
Discovery Laboratories (DSCO) Release: Surfaxin Process Validation Batches Achieve Stability Milestone to Enable Filing of Response to FDA Approvable Letter 10/1/2007  More...
U.S. FDA Looks for More Information on Endo Pharmaceuticals (ENDP)'s Frova 10/1/2007  More...
Amylin Pharmaceuticals, Inc. (AMLN) (Jobs) Says SYMLIN Pen-Injector Devices Use Without Mealtime Insulin Not Approvable 10/1/2007  More...
Novartis International AG (NVS) Painkiller Prexige Gets "Not Approvable" Letter in U.S. 9/27/2007  More...
IDM Pharma, Inc. (IDMI) Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma 8/27/2007  More...
Solvay Pharmaceuticals, Inc. Receives Approvable Letter from FDA with Respect to New Drug Application for CREON(R) 8/20/2007  More...
Indevus Pharmaceuticals, Inc. (IDEV) Gets Approvable Letter for Bladder Cancer Therapy 8/17/2007  More...
GlaxoSmithKline (GSK) (Jobs) Says FDA has Questions on Restless Legs Drug 8/13/2007  More...
FDA Deems Wyeth (WYE) (Jobs) and Solvay Pharmaceuticals, Inc. Schizophrenia Drug Not Approvable 8/10/2007  More...
GlaxoSmithKline (GSK) (Jobs) Receives Not Approvable Letter From FDA on Advair(R) 500/50 for COPD 8/8/2007  More...
Jazz Pharmaceuticals, Inc. (JAZZ) (Jobs) Says Solvay Pharmaceuticals, Inc. Gives FDA More Luvox Information 8/3/2007  More...
FDA Issues Second Approvable Letter for Pozen, Inc. (POZN) and GlaxoSmithKline (GSK)'s (Jobs) Trexima(TM); Approval Delayed 8/2/2007  More...
Wyeth (WYE) (Jobs) Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause; Heart, Liver Concerns with Drug 7/24/2007  More...
Biovail Corporation (BVF) Provides Update on BVF-033; Receives Non-Approval Letter From FDA 7/20/2007  More...
Neurochem, Inc. (NRMX) Receives Approvable Letter for Eprodisate (KIACTA(TM)) for Treatment of AA Amyloidosis; FDA Asks for More Data 7/18/2007  More...
Labopharm (DDS.TO) Says May Need Another Tramadol Trial 6/29/2007  More...
FDA Issues Approvable Letter for Johnson and Johnson Pharmaceutical R&D (NJ)'s (Jobs) RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania 6/21/2007  More...
New Pfizer Inc. (PFE) (Jobs) AIDS Drug Approval Delayed 6/21/2007  More...
Shire Pharmaceuticals Group plc (SHPGY) Receives Approvable Letter From FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD 6/21/2007  More...
FDA Issues Third Approvable Letter for Encysive Pharmaceuticals (ENCY)'s Thelin (Sitaxsentan Sodium) 6/18/2007  More...
Labopharm (DDS.TO) Receives Second Approvable Letter from FDA for Once-Daily Tramadol 6/1/2007  More...
FDA Issues Approvable Letter for Shire Pharmaceuticals Group plc (SHPGY)'s SPD465 for the Treatment of ADHD in Adults 5/21/2007  More...
Roche (RHHBY) Receives Approvable Letter for MIRCERA(R) in the United States; Drug Approval Delayed 5/21/2007  More...
Questcor Pharmaceuticals, Inc. (Headquarters) (QSC) Receives "Not Approvable" Letter for H.P. Acthar(R) Gel for Treatment of Infantile Spasms 5/14/2007  More...
Merck & Co., Inc. (MRK) (Jobs) Receives Approvable Letter from FDA for EMEND(R) (fosaprepitant dimeglumine) For Injection; FDA Seeks More Data 5/14/2007  More...
Cipher Pharmaceuticals (DND.TO) Receives Approvable Letter from FDA for CIP-TRAMADOL ER 5/4/2007  More...
Cipher Pharmaceuticals (DND.TO) Receives Approvable Letter from FDA for CIP-ISOTRETINOIN; FDA Seeks More Clinical Data 4/27/2007  More...
Merck & Co., Inc. (MRK) (Jobs) Receives Non Approvable Letter from FDA for Arcoxia (etoricoxib) 4/27/2007  More...
Wyeth (WYE) (Jobs) Receives Conditional Approval for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis 4/25/2007  More...
Cephalon, Inc. (CEPH) Says Drug 'Approvable' But Needs Warning 4/2/2007  More...
Cangene Corporation (CC:CNJ) Receives an Approvable Letter from the FDA for Human Growth Hormone 3/12/2007  More...
Nuvo Research Inc. (NRI.TO) Announces Further Update on Discussions With the FDA Related to Review of Pennsaid 3/8/2007  More...
AVANIR Pharmaceuticals (AVNR) (Jobs) Summarizes Outcome of FDA Meeting on Zenvia NDA; Additional Data Needed 2/28/2007  More...
Nuvo Research Inc. (NRI.TO) Says FDA Approval For Pennsaid May Be Delayed 2/9/2007  More...
GlaxoSmithKline (GSK) (Jobs) Receives Approvable Letter For New Indications For ARIXTRA(R) (Fondaparinux Sodium) Injection 2/2/2007  More...
AVANIR Pharmaceuticals (AVNR) (Jobs) Receives FDA Approvable Letter For New Formulation Of Currently Marketed Antipsychotic Drug FazaClo 1/31/2007  More...
Wyeth (WYE) (Jobs) Receives Approvable Letter From FDA For Pristiq (Desvenlafaxine Succinate) For The Treatment Of Major Depressive Disorder 1/24/2007  More...
Astellas Pharma Inc. (Jobs) Shares Fall On FDA News On Transplant Drug 1/24/2007  More...
Cipher Pharmaceuticals (DND.TO)'s Response To Approvable Letter For CIP-ISOTRETINOIN Accepted For Review By FDA 1/17/2007  More...
FDA Accepts Labopharm (DDS.TO)'s Response To Approvable Letter For Once-Daily Tramadol As Complete 1/16/2007  More...
Nuvo Research Inc. (NRI.TO) Receives Approvable Letter From U.S. FDA For Pennsaid 12/29/2006  More...
GlaxoSmithKline (GSK) Receives Approvable Letter For Topical Antibiotic, Altabax(TM) (retapamulin ointment), 1% 12/26/2006  More...
Allergan Inc. (AGN) Announces FDA Issues Approvable Letter For COMBIGAN(TM) (Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution) 0.2%/0.5% 12/22/2006  More...
New River Pharmaceuticals Inc. (NRPH) And Shire PLC Receive Approvable Letter For VYVANSE(TM) (lisdexamfetamine dimesylate) For The Treatment Of ADHD 12/22/2006  More...
Labopharm (DDS.TO) Submits Response To Approvable Letter For Once-Daily Tramadol To FDA 12/20/2006  More...
Genta Incorporated (GNTA) Receives Non-Approvable Notice For Application of Genasense(R) In Patients With Chronic Lymphocytic Leukemia 12/15/2006  More...
Encysive Pharmaceuticals (ENCY) Says FDA Finds Response To Thelin Incomplete 12/14/2006  More...
FDA Needs More Pozen, Inc. (POZN) Trexima Data; Company To Submit Revised Response To Approvable Letter By Year End 12/13/2006  More...
Anika Therapeutics (ANIK) Receives FDA Approvable Letter For Its Cosmetic Tissue Augmentation Product 11/29/2006  More...
FDA Accepts As "Complete Response" Oscient Pharmaceuticals Corporation (OSCI)'s Submission Following FACTIVE Approvable Letter For Five-Day CAP 11/27/2006  More...
Merck & Co., Inc. (MRK) Responds To FDA-Issued Approvable Letters For Arcoxia(R) (etoricoxib) 11/10/2006  More...
Pozen, Inc. (POZN) Submits Full Response To FDA Approvable Letter For Trexima(TM) 11/9/2006  More...
AVANIR Pharmaceuticals (AVNR) Receives FDA Approvable Letter For Zenvia For The Treatment Of Involuntary Emotional Expression Disorder 10/31/2006  More...
Columbia Laboratories, Inc. (CBRX) Comments On FDA Decision On Adeza Biomedical (ADZA)'s Gestiva 10/23/2006  More...
Adeza Biomedical (ADZA) Receives FDA Approvable Letter For Gestiva 10/23/2006  More...
FDA Issues Non-Approvable Letter For Replidyne, Inc.'s Faropenem 10/23/2006  More...
Amgen (AMGN) Receives Complete Response Letter For Extended Dosing Of Aranesp(R) For Patients With Chronic Kidney Disease And Anemia; FDA Seeks More Data 10/16/2006  More...
MGI PHARMA, INC. (MOGN) Receives Approvable Letter For Saforis(TM) (Glutamine) Powder in UpTec(TM) For Oral Suspension; FDA Seeks Another Trial Of Saforis 10/13/2006  More...
FDA Issues Approvable Letter For New River Pharmaceuticals Inc. (NRPH) And Shire Pharmaceuticals (SHPGY)'s NRP104 For The Treatment Of ADHD 10/9/2006  More...
FDA Issues Approvable Letter For Johnson and Johnson Pharmaceutical Research and Development, LLC (CA)'s Paliperidone ER For The Treatment Of Schizophrenia 10/2/2006  More...
Axcan Pharma (AXCA) Receives FDA Approval Letter For PYLERA'TM' -Formerly Known As HELIZIDE-, An Innovative 3-in-1 Capsule Triple Therapy For The Eradication Of Helicobacter Pylori 9/29/2006  More...
Labopharm (DDS.TO) Receives Approvable Letter From FDA For Once-Daily Tramadol 9/29/2006  More...
FDA Issues Approvable Letter To Ortec International Inc. (ORTN.OB) For Use Of Cryopreserved OrCel(R) In Epidermolysis Bullosa Patients' Hand Reconstructions And Donor Sites 9/29/2006  More...
FDA Receives Approvable Letter From Oscient Pharmaceuticals Corporation (OSCI) For FACTIVE(R) Tablets For Five-Day Treatment Of Community-Acquired Pneumonia; Regulators Request More Information 9/22/2006  More...
Uroplasty, Inc. (UPST) Receives FDA Approvable Letter For Macroplastique 9/13/2006  More...
Sanofi-Aventis (France) (SASY.PA) Gets Non-Approvable Letter From US FDA For Dronedarone 8/31/2006  More...
EPIX Pharmaceuticals (EPIX) Receives Response From The FDA Regarding Appeal Of Vasovist(TM) Approvable Letters 8/28/2006  More...
Merck & Co., Inc. (MRK) Moves Forward With Vioxx Successor 8/23/2006  More...
Merck & Co., Inc. (MRK) Provides Preliminary Analyses Of The Completed MEDAL Program For ARCOXIA(TM) (Etoricoxib); Merck Looks Forward To Reviewing The MEDAL Program Data With Regulatory Agencies And Intends To Respond To FDA-Issued ''Approvable'' Letter 8/23/2006  More...
Eli Lilly and Company (LLY) Announces Approvable Letter Issued By FDA For Arxxant(TM) (ruboxistaurin mesylate); FDA Requests Further Data Before Approval 8/18/2006  More...
Neurochem, Inc. (NRMX) Receives Approvable Letter For Eprodisate For Treatment Of AA Amyloidosis; FDA Asks For Additional Data Before Final Approval 8/14/2006  More...
FDA Extends Review Of EPIX Pharmaceuticals (EPIX)' Appeal Of Vasovist(TM) Approvable Letters 7/28/2006  More...
Encysive Pharmaceuticals (ENCY) Shares Dive After New Delay On Lung Drug 7/25/2006  More...
FDA Issues Approvable Letter To Cellegy Pharmaceuticals (CLGY) For Cellegesic(R) 7/10/2006  More...
EPIX Pharmaceuticals (EPIX) Files Appeal With FDA Regarding Vasovist(TM) Approvable Letters 7/5/2006  More...
Cephalon, Inc. (CEPH) Gets FDA Approvable Letter For Fentora 6/30/2006  More...
Wyeth (WYE) Contraceptive Delayed By Conditional Approval 6/29/2006  More...
Baxter Healthcare Corporation (BAX) Receives Tentative FDA Approvals For Ondansetron Injection In Vials And Premix Containers 6/16/2006  More...
Neurocrine Biosciences, Inc. (NBIX) Sleep Pill Indiplon May Need More Tests; Shares Plummet 6/16/2006  More...
Pozen, Inc. (POZN) And GlaxoSmithKline (GSK) Report Receipt Of Approvable Letter For Investigational Migraine Treatment; FDA Requests Additional Safety Information 6/9/2006  More...
Akzo Nobel N.V. (AKZOY) Menopause Treatment Denied U.S. Approval 6/2/2006  More...
Neurocrine Biosciences, Inc. (NBIX) Receives Approvable Letter For Indiplon Capsules And NON-Approvable For Indiplon Tablets For The Treatment Of Insomnia; Shares Plunge 5/16/2006  More...
Advancis Pharmaceutical Corporation Receives FDA Approval Letter For New Strengths Of Keflex 5/15/2006  More...
Cephalon, Inc. (CEPH) Receives Approvable Letter For NUVIGIL(TM) (Armodafinil) 5/2/2006  More...
The European Medicines Agency Recommends Sanofi-Aventis (France) (SASY.PA) Weight-Loss Pill 4/28/2006  More...
Chembio Diagnostics, Inc. (CEMI.OB) Receives FDA Approvable Letter For Its Rapid HIV Tests 4/19/2006  More...
Salix Pharmaceuticals, Ltd. (SLXP)'s MoviPrep(R) Issued Approvable Letter By FDA 4/11/2006  More...
FDA Gives GlaxoSmithKline (GSK) Tentative OK For OTC Diet Drug 4/10/2006  More...
FDA Seeks More Data On Discovery Laboratories (DSCO)'s Drug Surfaxin 4/5/2006  More...
Encysive Pharmaceuticals (ENCY) Shares Fall After FDA Asks For More Clinical Trial Data For Thelin Approval 3/27/2006  More...
FDA Issues Approvable Letter For Cubist Pharmaceuticals, Inc. (CBST)'s CUBICIN sNDA 3/27/2006  More...
NPS Pharmaceuticals, Inc. (NPSP) Receives Approvable Letter For PREOS NDA 3/10/2006  More...
Schwarz Pharma Has Approvable FDA Letter For Neupro 3/1/2006  More...
Novartis Corporation (NVS) Gets FDA Approvable Letter For Aclasta 2/27/2006  More...
Sanofi-Aventis (France) (SASY.PA) Received From The FDA An Approvable Letter For Rimonabant For Weight Management And A Non Approvable Letter For Smoking Cessation; Sanofi Shares Fall 2/20/2006  More...
FDA Issues Approvable Letter For Alkermes (ALKS)' VIVITROL(TM) (Formerly VIVITREX(R)), For The Treatment Of Alcohol Dependence 12/29/2005  More...
Shire Pharmaceuticals (SHPGY) Receives FDA Approvable Letter For DAYTRANA(TM) For The Treatment Of ADHD 12/27/2005  More...
MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG) Release: Dacogen(TM) (Decitabine) Injection Complete Response Accepted For Review By U.S. FDA 12/16/2005  More...
Trimeris, Inc. (TRMS) And Roche (RHHBY) Release: FDA Issues Approvable Letter In Response To Application For Use Of FUZEON With Needle-Free Injection Device 11/28/2005  More...
FDA Issues Approvable Letter For EPIX Pharmaceuticals (EPIX) Blood-Pool Contrast Agent Vasovist(TM); US Regulators Want Another Trial 11/23/2005  More...
Celgene (CELG) Receives Approvable Letter From FDA For THALOMID(R) In Treatment Of Newly Diagnosed Multiple Myeloma; FDA Requests Labeling Changes 11/15/2005  More...
SuperGen, Inc. (SUPG) And MGI Pharma Inc. (MOGN), Pull European Drug Application 11/15/2005  More...
FDA Rejects PPD, Inc. (PPDI) And Johnson & Johnson (JNJ)'s Premature Ejaculation Drug 10/27/2005  More...
Cephalon, Inc. (CEPH) ADHD Drug Takes Step Closer To Approval 10/21/2005  More...
Insmed Incorporated (INSM) Submits Response To FDA Approvable Letter For iPlex 10/18/2005  More...
Bristol-Myers Squibb Company (BMY) And Merck & Co., Inc. (MRK) Say FDA Seeks More Data On Pargluva 10/18/2005  More...
Valeant Pharmaceuticals International's (VRX) Zelapar "Approvable" By FDA 10/4/2005  More...
Insmed Incorporated (INSM) Issues Statement Regarding IPLEX(TM) Approvable Letter Press Release 9/29/2005  More...
Insmed Incorporated (INSM) Receives Approvable Letter For iPlex(TM) 9/28/2005  More...
Abbott Laboratories (ABT) Release: FDA Advisory Committee Does Not Recommend Approval Of Xinlay(TM) (atrasentan) 9/14/2005  More...
Cephalon, Inc. (CEPH) Receives FDA Approval To Market Sugar-Free Formulation Of ACTIQ(R) 9/13/2005  More...
Pfizer Inc. (PFE) Says FDA Doesn't Approve Osteoporosis Drug 9/13/2005  More...
MGI Pharma Inc. (MOGN) And SuperGen, Inc. (SUPG): Approvable Letter Received From The FDA For Dacogen(TM) (Decitabine) Injection For The Treatment Of MDS; FDA Asks For More Info 9/2/2005  More...
Barr Pharmaceuticals, Inc. (BRL) Says Oral Contraceptive Gets Approvable Letter 8/18/2005  More...
FDA Says It Needs More Information From Discovery Laboratories (DSCO) 8/15/2005  More...
Teva Pharmaceutical Industries Limited (TEVA) Receives Follow-Up Approvable Letter From FDA Regarding Agilect(R); Concerns Remain 8/5/2005  More...
Discovery Laboratories (DSCO) Submits Response To FDA Approvable Letter For Surfaxin For RDS In Premature Infants 8/1/2005  More...
Mentor Corporation (MNTR) Receives "Approvable Letter" From FDA For Its MemoryGel Silicone Gel-Filled Implants 7/29/2005  More...
STAAR Surgical (STAA) Receives Approvable Letter From FDA For VISIAN ICL(TM) 7/29/2005  More...
Spanish Biotechnology Company, Cellerix, S.L., Receives Orphan Status Designation By The European Medicines Evaluation Agency For A Stem Cell Medicinal Product 7/29/2005  More...
Forest Laboratories, Inc. (FRX) Announces FDA Decision On Supplemental New Drug Application For Namenda(R): A Non-Approvable Letter 7/26/2005  More...
Adolor Corporation (ADLR) Receives FDA Approvable Letter For Entereg(R) (Alvimopan); FDA Requests Additional Studies 7/22/2005  More...
Chiron Corporation (CHIR) Release: FDA Requests Additional Data On PULMINIQ(TM) (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States That PULMINIQ Is "Approvable" But Additional Study Is Required 7/15/2005  More...
FDA Accepts EPIX Pharmaceuticals' (EPIX) Submission Following Vasovist(TM) Approvable Letter As Complete Response; FDA Action Targeted For Late November 2005 7/1/2005  More...
Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) Receives Not Approvable Letter From FDA For Tipifarnib Based On Phase II Data 7/1/2005  More...
Penwest Pharmaceutical (PPCO) Receives Non-Approvable Letter From FDA For PW2101; Cease Development Of Drug 6/30/2005  More...
FDA Advisory Panel Voted Abiomed's (ABMD) AbioCor(R) Submission Did Not Yet Meet HDE Standards; Additional Data Is Requested 6/24/2005  More...
Connetics Corporation (CNCT) Receives FDA Non-Approvable Letter For Velac; Shares Plunge 6/13/2005  More...
Connetics Corporation (CNCT) To Resume Extina Development With New Phase III Trial 6/8/2005  More...
Mylan Laboratories Inc. (MYL) Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol 6/1/2005  More...
La Jolla Pharmaceutical Company (LJPC) Provides Update On Riquent; Warns Of Financing Shortage 5/31/2005  More...
Johnson and Johnson Pharmaceutical R&D (NJ) Receives Not Approvable Letter For RISPERDAL(R) In The Treatment Of Psychosis Of Alzheimer's Disease 5/26/2005  More...
Alcon Laboratories, Inc. (ACL) Receives Approvable Letter From FDA For RETAANE Suspension 5/25/2005  More...
Barrier Therapeutics, Inc. (BTRX) Receives Not Approvable Letter From The FDA For Zimycan(TM) 5/25/2005  More...
EPIX Pharmaceuticals (EPIX) Submits Response To FDA Approvable Letter For MS-325; Conference Call And Webcast Scheduled 5/23/2005  More...
Johnson and Johnson Pharmaceutical R&D (NJ) Receives Not Approvable Letter On RISPERDAL(R) In The Treatment Of Autism 5/20/2005  More...
Biovail Corporation (BVF) Receives Approval Letter From FDA For Tramadol ODT; Oral Disintegrating Tablet Version To Provide Treatment Option For Those Who Suffer From Moderate To Moderately Severe Pain 5/6/2005  More...
Alpharma Inc. (ALO) Receives FDA Approvable Status For Kadian(R) 200MG Capsules 5/5/2005  More...
Artes Medical Inc. Begins Qualification Of U.S. Manufacturing Of ArteFill; Company Takes Significant Next Step Toward Final FDA Approval 4/27/2005  More...
Barr Pharmaceuticals, Inc.'s (BRL) Receives Not Approvable Letter For Bijuva(TM) Vaginal Cream 4/26/2005  More...
Cellegy Pharmaceuticals (CLGY) Responds To FDA Inquiries Concerning Cellegesic(TM) 4/18/2005  More...
Sanofi-Aventis (France) (SASY.PA) Release: FDA Issues Approvable Letter For AMBIEN CR(TM) (Zolpidem Tartrate Extended Release) CIV For The Treatment Of Insomnia 4/11/2005  More...
Cyberonics Inc. (CYBX) Announces Conference Call To Discuss Closure Of FDA Warning Letter 4/7/2005  More...
Forest Laboratories, Inc. (FRX) Receives Non-Approvable Letter For Social Anxiety Disorder Indication For Lexapro(R) 3/31/2005  More...
Biovail Corporation (BVF) Updates Status Of NDA For Tramadol ER; Additional Clinical Trial Data Will Be Required 3/30/2005  More...
Cephalon (CEPH) Receives Approvable Letter To Market Sugar-Free Formulation Of ACTIQ(R) 3/25/2005  More...
Advanced Magnetics (AVM) Receives Approvable Letter From FDA For Combidex(R) 3/24/2005  More...





 

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