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Clinical - IND
Patient Deaths Push the FDA to Slap Full Clinical Hold on CTI BioPharma's Cancer Drug Pacritinib 2/10/2016
FDA Slaps Partial Clinical Hold on CTI BioPharma's Lead Product Candidate Pacritinib, Stock Crumbles 2/9/2016
Sangamo (SGMO) Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS I 2/8/2016
Acura Pharmaceuticals, Inc. (ACUR) Provides Development Update On Its LIMITX Abuse Deterrent Technology 2/2/2016
With Almost $200 Million in the Bank, WAVE Life Sciences (WVE) Plans Six Clinical Programs in Three Years 2/1/2016
Ariad (ARIA) Announces FDA Clearance To Begin Clinical Development Of AP32788 2/1/2016
Fate Therapeutics (FATE) Announces FDA Clearance Of Investigational New Drug Application For Protmune For Prevention Of Acute Gvhd And CMV Infection 1/27/2016
XTL Biopharmaceuticals Ltd. (XTLB) Announces Encouraging Feedback From U.S. FDA On Its Upcoming IND Filing For Lupus Drug Hcdr1 1/25/2016
Athenex Announces US FDA Allowance Of The Investigation New Drug Application Of Oradoxel, The Proprietary Oral Form Of Docetaxel 1/25/2016
Collegium (COLL) Announces FDA Acceptance Of IND Application For Abuse-Deterrent, Hydrocodone Deterx 1/21/2016
MultiCorp International, Inc. To Develop 4 Arm Study For Emergency Room Clinical Trials With Patented Migraine Medicine 1/21/2016
Tricida Announces FDA Acceptance Of Investigational New Drug Application For Lead Candidate TRC101 And Hiring Of Claire Lockey As Chief Development Officer And Edward J. Hejlek As General Counsel 1/13/2016
Juniper Pharma (JNP) Expands Lead Phase 2b Trial, Submits Pre-IND Meeting Request For Its First Intra-Vaginal Ring Product, And Adds Four Key Executives 1/11/2016
XTL Biopharmaceuticals Ltd. (XTLB) Submits Protocol To Yeda For Advanced Clinical Trial Of hCDR1 In The Treatment Of Lupus 1/11/2016
Evofem Holdings Announces Successful Completion Of Pre-IND Meeting For Amphora 1/11/2016
BeiGene Release: U.S. IND Becomes Active For BGB-A317, An Anti-PD-1 Monoclonal Antibody 1/11/2016
Prescient Therapeutics Release: FDA Allows PTX IND For Leukemia Phase Ib & II Trials 1/8/2016
Aeglea Announces FDA Acceptance Of Its Investigational New Drug Application For AEB1102 For The Treatment Of Arginase I Deficiency 1/7/2016
MabVax Therapeutics, Inc. Files IND For A Phase I Clinical Trial With 89Zr-Humab-5B1 1/6/2016
Vyome Biosciences Announces FDA Acceptance Of Investigational New Drug Application In The US For Its Lead Product VB-1953 To Treat Moderate-To-Severe Acne 1/6/2016
Lion Biotech Submits Investigational New Drug Application To Conduct Studies In Cervical, Head And Neck Cancer 1/4/2016
Nanobiotix Release: FDA Approved Investigational New Drug For NBTXR3 In A New Clinical Study In Prostate Cancer 1/4/2016
Minerva Neurosciences, Inc. (NERV): Enrollment Completed In MIN-101 EU Phase IIb Trial, IND Application Accepted By FDA 12/30/2015
Saronic Biotech Files Investigational New Drug Application With FDA For SBI1997 Phase I/II Clinical Trial 12/18/2015
FDA Lifts Advaxis (ADXS) Clinical Hold 12/16/2015
NephroGenex (NRX) Announces FDA Clearance Of IND Application For Clinical Study Of Intravenous Pyridorin In The Treatment Of Acute Kidney Injury 12/14/2015
X4 Pharma Announces FDA Allowance Of X4P-001 IND For Phase 1b/2a Study Of In Refractory Clear Cell Renal Cell Carcinoma 12/14/2015
Zafgen (ZFGN) Plunges Some More After FDA Orders Full Clinical Hold on Beloranib 12/3/2015
Sangamo BioSciences (SGMO) Announces FDA Clearance Of Investigational New Drug Application For SB-FIX, First In Vivo Protein Replacement Platform Program For Treatment Of Hemophilia B 12/1/2015
Galmed Pharmaceuticals Announces FDA Clearance Of IND Of Aramachol For The Treatment Of Patients With HIV-Associated Lipodystrophy And Nonalcoholic Fatty Liver Disease 12/1/2015
Sunesis (SNSS) Announces First Patient Treated In Indiana University Pilot Study Of Vosaroxin And Cytarabine In Adults Age 60 Years And Older With Previously Untreated AML 12/1/2015
MabVax Therapeutics, Inc. Files IND For Phase I Clinical Trial With Humab 5B1 As A Therapeutic For Pancreatic Cancer 12/1/2015
Rich Pharma Announces Additional Submission To The FDA 11/23/2015
Glaukos Submits IND Application To FDA To Study iDose Travoprost Intraocular Implant In Glaucoma Patients 11/20/2015
Aduro Biotech (ADRO) Receives Milestone Payment From Janssen Pharmaceutical For Submission Of Investigational New Drug Application For ADU-741 In Prostate Cancer 11/18/2015
Oragenics, Inc. (OGEN) Announces Successful Completion Of Pre-IND Meeting For OG253 11/18/2015
Regen BioPharma Submits Response To FDA Questions On Hemaxellerate Investigational New Drug Application 11/17/2015
Viking Therapeutics (VKTX) Submits Investigational New Drug (IND) Application To Conduct Phase 2 Clinical Trial Of VK2809 In Patients With Hypercholesterolemia And Fatty Liver Disease 11/17/2015
aTyr Pharma Selects Second IND Candidate, The First Engineered Physiocrine For GMP Process Development And For Potential Treatment Of Severe Lung Diseases 11/11/2015
Immune Pharma Announces FDA Acceptance Of Investigational New Drug (IND) Application In The U.S. For Bertilimumab For The Treatment Of Bullous Pemphigoid 11/9/2015
Theravance Biopharma (TBPH) Submits Investigational New Drug (IND) Application For TD-1473, A GI-Targeted Pan-Janus Kinase (JAK) Inhibitor 11/3/2015
AGTC (AGTC) Files Investigational New Drug Application For The Treatment Of Achromatopsia Caused By Mutations In The CNGB3 Gene 11/2/2015
TetraLogic Pharmaceuticals (TLOG) Announces The Opening Of An IND For SHAPE Gel In Alopecia Areata 11/2/2015
Daiichi Sankyo and Bay Area’s Plexxikon Inc. Win Breakthrough Tag for Pexidbartini 11/2/2015
Tyme Technologies Receives FDA Acceptance Of Investigational New Drug Application For Oncology Drug Candidate, SM-88 10/27/2015
Turing Pharmaceuticals AG Announces FDA Acceptance Of Investigational New Drug Application And Fast Track Designation For TUR-004 10/23/2015
Can-Fite BioPharma (CFBI) Release: New Study Demonstrates CF602 Mechanism Of Action To Improve Sexual Dysfunction 10/22/2015
CytoDyn Files An IND And Full Protocol For Phase II Study In GvHD 10/20/2015
Galectin' GR-MD-02 To Be Studied In Combination With Keytruda In Patients With Metastatic Melanoma 10/19/2015
Inovio Pharma (INO) And Partner Advance MERS Vaccine 10/19/2015
Theravance Biopharma (TBPH) Submits Investigational New Drug (IND) Application For TD-0714, An Inhibitor Of Neprilysin (NEP) 10/13/2015
Nektar Therapeutics (NKTR) Chief Science Officer Provides Details on Immuno-Oncology, Pain Pipelines 10/13/2015
Immune Pharmaceuticals, Inc. Submits Investigational New Drug Application (IND) In The U.S. For Its Lead Product Candidate Bertilimumab For The Treatment Of Bullous Pemphigoid 10/7/2015
Rich Pharmaceuticals Retains Theradex® To Finalize Investigational New Drug Application And Initiate Next Phases Of Clinical Trials 10/7/2015
Kadimastem Submitted Pre-IND Package To The FDA 10/7/2015
Otonomy (OTIC) Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311 10/5/2015
Fibrocell Science, Inc. And Intrexon Provide Regulatory Update For FCX-007 For The Treatment Of Recessive Dystrophic Epidermolysis Bullosa (RDEB) 9/25/2015
ESSA Pharma Receives FDA Approval To Commence Clinical Development 9/24/2015
Aeglea Announces FDA Acceptance Of Investigational New Drug Application For AEB1102 9/14/2015
Dimension Therapeutics Announces FDA Acceptance Of Investigational New Drug Application And Orphan Drug Designation For Lead Candidate DTX101 In Patients With Hemophilia B 9/10/2015
Pluristem Therapeutics (PSTI) Completed Successful Meeting With The U.S. FDA In Preparation For Filing An IND For PLX-R18 To Treat Incomplete Hematopoietic Recovery After Bone Marrow Transplantation 9/9/2015
Dicerna (DRNA) Submits Investigational New Drug (IND) Application For DCR-PH1, An Investigational Therapy For Primary Hyperoxaluria Type 1 (PH1) 9/2/2015
Bionomics Limited (BNO.AX) Release: Successful BNC101 IND Submission Paves Way For Development Of Promising Cancer Stem Cell Drug Candidate 8/31/2015
Portage Biotech's PPL Will Advance Its Lead Candidate PPL-003 To An IND For Dry Eye Disease And Uveitis 8/31/2015
Portage Biotech's Biohaven's Lead Drug Candidate Clears FDA Investigational New Drug Application (IND) Review And Clinical Studies To Begin 8/24/2015
Epizyme (EPZM) Announces Acceptance Of Investigational New Drug Application For Tazemetostat In Patients With INI1-Negative Tumors Or Synovial Sarcoma 8/24/2015
RetroSense Therapeutics’ Lead Gene Therapy Candidate Gets FDA Clearance To Proceed To First-In-Human Clinical Trials 8/24/2015
TapImmune Inc. (TPIV) Completes Transfer of IND From The Mayo Clinic 8/18/2015
La Jolla Pharma (LJPC) Announces FDA Acceptance Of IND For LJPC-401 8/11/2015
Regen BioPharma Progresses In FDA Responses To dCellVax Clinical Trial Questions 8/10/2015
TRACON Pharmaceuticals, Inc. (TCON) Reports Second Quarter 2015 Financial Results And Provides Corporate Update 8/6/2015
FDA OKs Juno (JUNO)'s IND for Lead Leukemia Candidate JCAR015 8/3/2015
Mundipharma EDO Gmbh Announces FDA Investigational New Drug Approval Of Its First Anti-Cancer Compound, EDO-S101, For The Treatment Of Patients With Relapsed/Refractory Haematologic Malignancies And Solid Tumours 7/31/2015
Ignyta (RXDX) Announces FDA Clearance Of IND For RXDX-107 7/29/2015
KaloBios Pharmaceuticals, Inc. (KBIO) Announces FDA Clearance Of Investigational New Drug Application For KB003 In Patients With Chronic Myelomonocytic Leukemia 7/29/2015
FibroGen, Inc. (FGEN) Receives FDA Clearance to Proceed With Clinical Study of FG-3019 in Duchenne Muscular Dystrophy 7/28/2015
Portage Biotech's Biohaven Announces IND Filing For Bhv-0223 For Phase 1 Clinical Testing 7/23/2015
Fibrocell Science, Inc. And Intrexon Announce IND Filing Of FCX-007 For The Treatment Of Recessive Dystrophic Epidermolysis Bullosa (RDEB) 7/20/2015
Goodwin Biotechnology, Inc. Announces The Completion Of cGMP Manufacturing Of An IgM Monoclonal Antibody And IgM : Ligand Conjugate For Q Therapeutics, Inc., And Successful Clearance Of Q Therapeutics' IND Submission For Q-Cells Cell Therapy In ALS 7/13/2015
Adaptimmune Announces FDA Acceptance Of Investigational New Drug (IND) Application For MAGE-A10 T In Patients With Non-Small Cell Lung Cancer 7/2/2015
TRACON Pharmaceuticals, Inc. (TCON) Announces IND Filing Of DE-122 (TRC105) For The Treatment Of Wet Age-Related Macular Degeneration By Santen Pharmaceutical 7/1/2015
Circadian Technologies Limited (CIR.AX) Commences Wet AMD OPT-302 Clinical Trial 7/1/2015
Juno Therapeutics (JUNO) Announces FDA Acceptance Of Investigational New Drug Application For JCAR017 In Relapsed/Refractory B Cell Non-Hodgkin Lymphoma 6/29/2015
TxCell Announces FDA Acceptance Of IND For Ovasave 6/29/2015
BeiGene Co.,Ltd Announces IND Approval For BGB-3111, A Bruton Tyrosine Kinase Inhibitor 6/19/2015
BiondVax Pharmaceuticals Announces FDA Acceptance Of IND Application For Its Investigational Universal Flu Vaccine 6/17/2015
Genticel Receives FDA Clearance Of IND Application For U.S. Phase I Clinical Trial Of GTL001 (Procervix), Company's First-In-Class HPV Therapeutic Vaccine Candidate 6/16/2015
Sucampo (SCMP) Release: China Food And Drug Administration Accepts IND For Pivotal Study Of AMITIZA (Lubiprostone) 6/16/2015
U.S. FDA Reactivates Prescient Therapeutics's IND For PTX-100 Breast Cancer Trial 6/10/2015
Stemedica Cell Technologies, Inc. Release: FDA Grants IND Approval For Phase Iia Clinical Trial Using Stemedica's itMSC Therapy To Treat Alzheimer's Disease 6/9/2015
Goodwin Biotechnology, Inc. And Aspyrian Therapeutics Collaborate On The Successful GMP Manufacturing And IND Submission For A Novel Antibody Drug Conjugate (ADC) Platform 6/9/2015
National Cancer Institute Accepts Rexahn Pharmaceuticals, Inc. (RNN)'s RX-21101 For Its Nanotechnology Characterization Laboratory's Preclinical Characterization Program 6/8/2015
Q Therapeutics, Inc. Release: Novel Cellular Therapeutic Approach For ALS Gets FDA Clearance For First-In-Human Trials 6/4/2015
Advaxis, Inc. Announces FDA Clearance Of Investigational New Drug Application For Phase 2 Study Of ADXS-HPV And Incyte (INCY)'s Epacadostat For The Treatment Of HPV-Associated Early Stage Cervical Cancer 6/1/2015
ProLynx Announces Active IND Of A Novel Ultra-Long Acting PEG–SN-38 Conjugate To Treat Solid Tumors 6/1/2015
ASCO15: Affimed Therapeutics AG (AFMD) ASCO Data For The CD33/CD3-Tandab Program Demonstrate That CD33 And CD3 Binding Affinities Correlate With Potent T-Cell Activation And Cytotoxicity 5/29/2015
MicroBiome Therapeutics LLC Receives Positive Response From FDA For Use Of Expedited Regulatory Pathway For Diabetes Drug Nm505 5/12/2015
Aspyrian Therapeutics Inc. Announces FDA Acceptance Of An Investigational New Drug Application For RM-1929, A First-In-Class, Precision-Targeted Therapy For Cancer 5/12/2015
Gemmus Pharma Announces FDA Acceptance Of IND Application For GP1681 - A Novel Host-Based Drug Candidate For Influenza 5/11/2015
FDA Puts ESSA Pharma's IND on Clinical Hold 5/4/2015
C-FDA Approves IND For D-Pharm Ltd.'s Anti-Epileptic Drug, DP-VPA In China 4/14/2015
FDA Modifies Partial Clinical Hold On Tekmira (TKMR)'s TKM-Ebola IND To Allow Multiple Dosing Of Healthy Volunteers 4/10/2015
Anika Therapeutics (ANIK) Files IDE Application With U.S. FDA For Hyalofast 4/9/2015
ArmaGen Technologies, Inc. Announces FDA Acceptance Of IND Application For AGT-181 For The Treatment Of Hurler Syndrome 4/8/2015
ESSA Pharma Announces Filing Of Investigational New Drug Application For EPI-506 4/1/2015
Prescient Therapeutics Receives Approval From U.S. FDA To Transfer IND Sponsorship For Lead Drug Candidate PTX-200 4/1/2015
Neurotech Announces FDA Acceptance Of Investigational New Drug Application And Clinical Trial Initiation Of Novel Therapy For Wet AMD 3/30/2015
IntelliPharmaCeutics Reports Positive Topline Data Results From A Series Of Phase I Clinical Trials Of Its Abuse-Deterrent Rexista(TM) Oxycodone XR Tablets, And Files An IND For Rexista(TM) Oxycodone XR 3/30/2015
Investigational New Drug Application For WuXi PharmaTech Co., Ltd. MedImmune (AZN)'s Monoclonal Antibody Accepted For Review By CFDA 3/27/2015
Amarantus BioSciences, Inc. Opens Investigational New Drug (IND) Application With The U.S. FDA Allowing The Start Of A Phase 2b Program Of Eltoprazine In Parkinson's Disease Levodopa-Induced Dyskinesia 3/26/2015
Immunomic Therapeutics Receives Positive Feedback From FDA Following Pre-IND Discussions for Its Proprietary Peanut Allergy Vaccine 3/25/2015
FDA Accepts Invion Limited Proposal To Progress Development Of Inhaled Nadolol To Treat Chronic Respiratory Diseases 3/23/2015
BioPharmX Corporation Completes Pre-IND Meeting With U.S. FDA To Review Its Topical Acne Solution 3/18/2015
Egalet Earns $10 Million Milestone Payment Triggered By Advancement Of Shionogi, Inc.'s Abuse-Deterrent, Extended-Release Hydrocodone, S-718632, Using Egalet's GuardianTechnology 3/17/2015
ADC Therapeutics Submits Its First IND For A Novel Antibody Drug Conjugate Against Lymphomas 3/16/2015
Cellceutix (CTIX) Advancing Treatment for Hidradenitis Suppurativa, Pre-IND Meeting Request To FDA 3/16/2015
BioBlast Pharma (ORPN) Receives IND Clearance To Commence Clinical Trial For Cabaletta For The Treatment Of OPMD 3/12/2015
Applied Genetic Technologies Corporation Files Investigational New Drug Application For The Treatment Of X-Linked Retinoschisis 3/10/2015
Corbus Pharmaceuticals, Inc.' IND Receives Clearance From FDA To Initiate Phase 2 Trials In Scleroderma With Its Novel Specialized Pro-Resolving Mediator Drug Resunab 3/9/2015
Mersana Therapeutics Nabs $35 Million And A New CEO 3/3/2015
Otic Pharma Announces Encouraging Feedback From A Pre-IND Meeting With The FDA 2/23/2015
Sangamo BioSciences, Inc. (SGMO) Announces FDA Acceptance Of IND To Initiate Clinical Trial Of Its Novel ZFP Therapeutic® For Beta-Thalassemia 2/4/2015
Rich Pharmaceuticals Announces Completion of the Manufacture of RP-323 Study Drug in Connection with Obtaining FDA's Final Approval of The Investigational New Drug (IND) Application For The Treatment of Acute Myelocytic Leukemia 2/4/2015
Lion Biotechnologies, Inc. Announces Allowance Of IND Application To Begin New Phase 2 Study In Metastatic Melanoma 2/2/2015
Lpath, Inc. (LPTN) Submits Investigational New Drug Application For Lpathomab For Neuropathic Pain 2/2/2015
Leading BioSciences Recieves FDA IND Clearance To Proceed With A Randomized, Multi-Center Phase 2 Clinical Trial Using Lb1148 To Treat Septic Shock 2/2/2015
MediciNova, Inc. Announces An Open Investigational New Drug (IND) Application For MN-001 In NASH 1/28/2015
Pharmalink Announces An Open Investigational New Drug (IND) Application For Nefecon® 1/21/2015
Celsus Therapeutics (CLTX) Announces FDA Allowance Of IND For Clinical Development Of MRX-6 Cream In Atopic Dermatitis 1/12/2015
Milestone Pharmaceuticals Receives FDA Clearance Of MSP-2017 Phase 2 IND 1/12/2015
BioPharmX Corporation Granted Pre-IND Meeting With U.S. FDA To Review Its Topical Acne Solution 1/12/2015
Sirnaomics And Partner Submit IND To CFDA For Its First Anti-Fibrosis siRNA Therapeutic 1/5/2015
Aldeyra Therapeutics (ALDX) Submits IND Filing To FDA For Clinical Testing Of NS2 In Patients With Sjogren-Larsson Syndrome 1/5/2015
RegeneRx Biopharmaceuticals, Inc. (RGRX) Partner Submits Phase 2B/3 IND To Korean Health Authority For RGN-259 For The Treatment Of Dry Eye Syndrome 12/29/2014
Kite Pharma, Inc. (KITE) Submits Investigational New Drug Application For Phase 1/2 Trial Of KTE-C19, Anti-CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy, For The Treatment Of Refractory Aggressive Non-Hodgkin Lymphoma 12/23/2014
Matinas BioPharma Provides Update On Clinical Development Program For MAT9001 Following FDA Feedback On IND Submission 12/23/2014
FDA Accepts IND Application For Radius (RDUS)'s Investigational Drug RAD1901 Being Developed For Potential Use In Metastatic Breast Cancer 12/22/2014
Pfenex Inc. (PFNX) Announces Active IND And Additional BARDA Funding For Recombinant Anthrax Vaccine Program, Px563L 12/22/2014
Aldeyra Therapeutics (ALDX) Submits FDA IND Filing for Noninfectious Anterior Uveitis 12/18/2014
Portage's Biohaven Receives Response From FDA To Its Pre-IND Meeting Request 12/18/2014
HedgePath Pharmaceuticals Receives IND Clearance To Commence Development Of Its Proposed Cancer Treatment 12/16/2014
Advaxis, Inc. Announces FDA Acceptance Of Its Investigational New Drug Application To Commence Clinical Trials Of ADXS-HPV In Combination With MedImmune (AZN)'s MEDI4736 For The Treatment Of HPV-Associated Cancers 12/15/2014
Synageva BioPharma (GEVA) Announces Active Investigational New Drug Application For SBC-103 For The Treatment Of Mucopolysaccharidosis IIIB 12/15/2014
Arrowhead Research Corporation (ARWR) Files IND For RNAi Therapeutic ARC-520 To Begin Phase 2b Multiple-Dose Studies In Chronic Hepatitis B Patients 12/15/2014
Batu Biologics Submits Investigational New Drug Application For Lung Cancer Anti-Angiogenic Immunotherapy With FDA 12/12/2014
ArmaGen Announces FDA Acceptance Of IND Application For AGT-182 for the Treatment Of Hunter Syndrome 12/11/2014
Boston Therapeutics, Inc. Announces FDA Acceptance Of IND To Initiate A Clinical Trial Of BTI-320 To Treat Type ll Diabetes And Weight Loss 12/11/2014
Lakewood-Amedex Inc. Submits Investigational New Drug Application For Bisphosphocin Nu-3 For The Treatment Of Diabetic Foot Infections 12/11/2014
KemPharm, Inc. Completes Pre-IND Meeting With FDA For NME Prodrug Of Hydromorphone, KP511 12/9/2014
Advaxis, Inc. Announces FDA Acceptance Of Its Investigational New Drug Application To Commence Clinical Trials Of ADXS-PSA In Combination With Merck & Co. (MRK)'s KEYTRUDA® (Pembrolizumab) For Prostate Cancer 12/8/2014
BioPharmX Corporation Announces Submission Of Pre-IND Meeting Request To The U.S. FDA For Its Topical Acne Solution 12/3/2014
ContraFect Corporation (CFRXU) Submits Complete Response To IND Clinical Hold For CF-301 12/2/2014
Hovione Files its First Investigational New Drug Application With The FDA 12/1/2014
BioRestorative Therapies, Inc. Schedules Pre-IND Meeting With FDA 11/24/2014
Cesca Therapeutics Announces Filing Of U.S. Pivotal IDE Application For No-Option Critical Limb Ischemia ("CLI") 11/24/2014
HedgePath Pharmaceuticals Files IND Application 11/18/2014
Fibrocell Science, Inc. Announces IND Allowed To Proceed To Develop New Treatment For Wounded Warrior Amputees To Prevent Stump Skin Diseases 11/18/2014
CytoTools AG: Clinical Development Program For The Wound Healing Drug DermaPro® Now Extended To US Pharmaceuticals Market 11/17/2014
Leading BioSciences Submits Expanded Access, Compassionate Use IND For LB1148 To Treat Ebola-Related Shock And Multi-Organ Failure 11/6/2014
FDA Issues IND Number For Regen BioPharma 's dCellVax Therapeutic Application, A Proposed Treatment For Breast Cancer 11/4/2014
Geron Corporation (GERN) Soars As The FDA Removes Full Clinical Hold On Imetelstat 11/4/2014
Ebola Clinical Trials: Big Name Players In The Ebola Race 10/28/2014
Antisense Therapeutics Limited (ANP.AX) Release: ATL1102 For MS – FDA Response To Phase 2b Study Plans 10/24/2014
Rich Pharmaceuticals Announces Submission Of Investigational New Drug (IND) Application To FDA For The Treatment Of Acute Myelocytic Leukemia And Myelodysplastic Syndrome 10/23/2014
TONIX Pharmaceuticals, Inc. (TNXP) Receives IND Clearance For TNX-201 In Episodic Tension-Type Headache 10/21/2014
AbGenomics Corporation Announces IND Filing For Abgn-168H (Neihulizumab) To Treat Psoriatic Arthritis 10/17/2014
Regen BioPharma Files IND Application With FDA For dCellVax Breast Cancer Immune Therapy 10/8/2014
Ebola Patient Gets Chimerix, Inc. (CMRX) Drug, Clinical Trials Planned 10/7/2014
FDA Approves NeuroGenetic Pharmaceuticals, Inc. Application To Begin Clinical Trials For Its NGP 555 Compound To Treat And Prevent Alzheimer’s Disease 9/29/2014
CorMedix (CRMD) Announces FDA IND Filing For Neutrolin® In United States 9/25/2014
Medunik Canada Announces Health Canada Priority Review Of PHEBURANE© Indicated For The Treatment Of Urea Cycle Disorders (UCD) 9/25/2014
Emergency Use Of Tekmira Pharmaceuticals Corporation (TKMR)'s Ebola Drug Cleared By FDA, Health Canada 9/24/2014
Fibrocell Science, Inc. And Intrexon Corporation Advance GM-HDF-COL7 Toward Clinical Development For The Treatment Of Recessive Dystrophic Epidermolysis Bullosa 9/24/2014
Antisense Therapeutics Limited (ANP.AX) Release: ATL1102 For MS Further Development Plans – U.S. FDA Pre-IND Response Timing Confirmed; European Patent Allowance 9/16/2014
Sangamo BioSciences, Inc. (SGMO) Announces Target Date For First IND For Sangamo's In Vivo ZFN Genome-Editing Platform For Monogenic Diseases 9/10/2014
Molecular Templates Inc. Templates Announces FDA Approval Of Investigational New Drug Application For CD20 Internalizing Immunotoxin MT-3724 9/8/2014
Cellectar Biosciences  (NVLT) Announces Acceptance Of Investigational New Drug Application To Evaluate I-131-CLR1404 In Clinical Trials In Relapsed Or Refractory Multiple Myeloma 9/4/2014
Glenmark Pharmaceuticals Enters Oncology With The Discovery And Initiation Of IND Enabling Studies Of An Innovative Bispecific Antibody 8/20/2014
ViaCyte, Inc. (Formerly Known as Novocell, Inc.) Announces FDA Acceptance Of IND To Commence Clinical Trial Of VC-01™ Candidate Cell Replacement Therapy For Type 1 Diabetes 8/19/2014
FDA Grants Orphan Drug Designation For Oncosynergy's Investigational Monoclonal Antibody OS2966 In The Treatment Of Glioblastoma 8/12/2014
Phosphagenics Limited (POH.AX) Completes First IND Enabling Study For TPM(R) / Oxymorphone Patch 8/11/2014
Cellectar Biosciences  (NVLT) Files Investigational New Drug Application To Evaluate I-131-CLR1404 In Clinical Trials In Relapsed Or Refractory Multiple Myeloma 8/11/2014
IntelliCell BioSciences (SVFC) Files Pre-IND With FDA For Osteoarthritis Lead By Dr. James Andrews 8/4/2014
Fate Therapeutics (FATE) Announces FDA Clearance Of IND For Clinical Development Of PROHEMA In Inherited Metabolic Disorders 7/30/2014
Stemline Therapeutics, Inc. (STML) Announces Opening Of SL-401 Corporate IND And Start Of Clinical Trials In BPDCN And AML 7/28/2014
Lorus Therapeutics Inc. (LRP) Receives FDA Clearance Of IND To Initiate LOR-253 Clinical Program In Patients With AML, MDS And Other Blood Cancers 7/28/2014
MacroGenics, Inc. (MGNX)'s DART Candidate IND For Colorectal Cancer, MGD007, Cleared To Start Enrolling Patients 7/25/2014
Kinex Pharmaceuticals Announces Allowance Of The Investigational New Drug (IND) Application For KX2-391 Ointment By The United States FDA 7/24/2014
MiMedx Files Its Initial Investigational New Drug Application 7/23/2014
Lightlake Therapeutics Inc. (LLTP) Files Investigational New Drug Application For Naloxone Nasal Spray For Reversing Opioid Overdose And Announces A Further Collaboration With The National Institute On Drug Abuse 7/23/2014
Galmed Pharmaceuticals Announces FDA Clearance Of IND Of Armachol For The Treatment Of Fatty Liver Disorders 7/22/2014
AVANIR Pharmaceuticals (AVNR) Announces FDA Acceptance Of IND For AVP-786 For The Adjunctive Treatment Of Major Depressive Disorder 7/21/2014
InterMune, Inc. (ITMN) Grabs FDA Breakthough Therapy Designation For IPF Drug Pirfenidone 7/18/2014
ViaCyte, Inc. (Formerly Known as Novocell, Inc.) Files Investigational New Drug Application And Device Master File With FDA For Novel Cell Replacement Therapy Product Candidate Designed To Treat Patients With Type 1 Diabetes 7/17/2014
AtheroNova Inc. (AHRO.OB) Announces Pre-IND Filing Under Section 505(b)(2) 7/15/2014
Rock Creek Pharmaceuticals Issues Update On U.S. Investigational New Drug Application 7/14/2014
FDA To Expedite Review Of Purdue Pharma L.P. Once-Daily Painkiller Tablet 7/8/2014
University of Pennsylvania's Personalized Cellular Therapy For Leukemia Receives FDA's Breakthrough Therapy Designation 7/7/2014
Curis, Inc. (CRIS) Announces Investigational New Drug Application Filing By Roche (RHHBY) To Initiate A Phase 2 Study Of Erivedge® (Vismodegib) In Idiopathic Pulmonary Fibrosis 6/23/2014
RegeneRx Biopharmaceuticals, Inc. (RGRX) Release: Chinese FDA Accepts Phase 2 IND For RGN-259 For Dry Eye 6/23/2014



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