News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter

Clinical - IND
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
MiMedx Expects To File Its First Investigational New Drug Application In July 6/19/2014
GW Pharmaceuticals Announces Physician Reports Of Epidiolex®: Treatment Effect In Children And Young Adults With Treatment-Resistant Epilepsy From Physician-Led Expanded Access Treatment Program 6/17/2014
Regen BioPharma , A Majority Owned Subsidiary Of Bio-Management, Provides Update On Hemaxellerate I™ IND For Treatment Of Drug Resistant Aplastic Anemia 5/13/2014
GW Pharmaceuticals Receives Investigational New Drug (IND) From FDA For Phase 2/3 Clinical Trial Of Epidiolex® In The Treatment Of Dravet Syndrome 5/7/2014
Kinex Pharmaceuticals Receives FDA Allowance For Oratecan, An Oral Form Of Irinotecan With Enhanced Gastrointestinal Absorption, The Second U.S. IND Based On The Orascovery Technology Platform 5/5/2014
Ruthigen Submits Investigational New Drug (IND) Application For Clinical Trial Of RUT58-60 5/2/2014
NeuroNascent, Inc. Successfully Completes Pre-IND Meeting With FDA For Alzheimer's Disease Therapeutic 4/22/2014
Stemline Therapeutics, Inc. (STML) Announces FDA Acceptance Of IND For SL-701, A Synthetic Multi-Peptide Vaccine Targeting Glioma Brain Tumors 4/8/2014
FDA Lifts Clinical Hold On Oxygen Biotherapeutics, Inc. (OXBT)'s Program 3/31/2014
Geron Corporation (GERN) Says FDA Halts Patient Enrollment In Another Cancer Trial 3/21/2014
Summit Corporation Announces FDA Clearance Of IND Application For Phase 2 Study Of SMT19969 To Treat C. Difficile Infection 3/18/2014
IntelliCell BioSciences (SVFC) Announces It Will File An IND For Osteoarthritis Of The Knee In Conjunction With The Andrews's Research And Educational Foundation 3/17/2014
PharmaRoth Labs, Inc. Announces Results From FDA Application 3/17/2014
Geron Corporation (GERN) Tanks As FDA Halts Development Of Blood Disorder Drug 3/13/2014
Celsus Therapeutics (CLTX) Provides Update On MRX-6 From FDA Pre-IND Meeting 3/12/2014
Alcobra (ADHD) Announces FDA Clearance Of IND For Metadoxine Extended Release (MDX) 3/6/2014
Omeros Corporation (OMER) Submits IND To Advance OMS721 Phase 2 Clinical Program 3/4/2014
TONIX Pharmaceuticals, Inc. Completes Pre-IND Meeting With FDA On TNX-201 For Episodic Tension-Type Headache: Clinical Development To Begin In 4Q 2014 3/3/2014
Ignyta Announces Submission Of IND For RXDX-101 2/27/2014
rEVO Biologics Announces The Submission Of An IND For Atryn® In Preeclampsia 2/25/2014
International Stem Cell Corporation Completes Pre-IND Meeting With FDA For Parkinson's Disease Cell Therapy 2/18/2014
Regado Biosciences, Inc. (RGDO), Announces FDA Acceptance Of IND For REG2 2/13/2014
BioMarin Pharmaceutical Inc. (BMRN) Announces Selection Of NAGLU Fusion Protein Drug Development Candidate BMN 250 For The Treatment Of Sanfilippo B (MPS IIIB) 2/11/2014
Galectin Therapeutics Supports Investigational New Drug (IND) Application For Its Galectin Inhibitor GR-MD-02 In Metastatic Melanoma 1/15/2014
Benitec, Inc. (BLT.AX) Release: Hepatitis C Trial To Proceed 1/14/2014
Wilson Therapeutics Announces Successful Filing Of U.S. IND To Advance WTX101 Development Program For Wilson Disease 1/14/2014
Kala Pharmaceuticals Announces IND Submission Of Its MPP-Formulated Loteprednol Etonbonate (LE-MPP) For Post-Cataract Surgery 1/6/2014
Harvard Apparatus Regenerative Technology Files Pre-IND Meeting Documents And Orphan Biologics Application With U.S. FDA 1/6/2014
Cellceutix (CTIX) Submits Application To Institutional Review Board to Commence Clinical Trials Of Anti-Psoriasis Drug Prurisol 1/6/2014
FDA Lifts Hold On Studies Testing Cell Therapeutics, Inc. (CTIC)'s Cancer Drug Tosedostat 1/2/2014
Shield Therapeutics Release: FDA Grants Approval Of IND To Commence A Phase 3 Pivotal Study For ST10 For The Treatment Of Iron Deficiency Anemia In Chronic Kidney Disease 12/16/2013
Interim Results From Gentium S.p.A.'s Treatment IND For Defibrotide And Additional Data On Defibrotide In The Prevention Of Acute Graft Versus Host Disease (Agvhd) Presented At The American Society of Hematology Annual Meeting 12/11/2013
Raptor Pharmaceutical Inc. (RPTP) Submits IND For RP103 For Leigh Syndrome And Other Mitochondrial Disorders 12/10/2013
Coronado Biosciences (CNDO) Announces IND Submission For TSO For The Treatment Of Moderate To Severe Chronic Plaque Psoriasis 12/9/2013
ARCA biopharma Announces FDA Acceptance Of Gencaro IND Application For The Treatment Of Atrial Fibrillation 12/4/2013
Chikujee Initiates IND-Enabling Study For Programmable Therapeutic-CT-187MDR For The Treatment Of Multidrug Resistant Ovarian Cancer 11/15/2013
Discovery Laboratories (DSCO) Receives FDA Clearance Of IND To Initiate AEROSURF® Phase 2 Clinical Program 11/13/2013
Innate Pharma (IPH.PA ): Launch of IND-Enabling Studies for IPH4102 11/8/2013
Star Scientific , Inc. Announces Leadership Transition, Acceleration of Plans for Submission of an IND to FDA for Pharmaceutical Version of Anatabine Compound 11/8/2013
Aclaris Therapeutics Initiates IND-Directed Program for A-101 for the Treatment of Seborrheic Keratosis, Common Type of Skin Tumor 11/6/2013
Repros Therapeutics Inc. (RPRX) Receives FDA Guidance for Proellex® Low Dose Oral Uterine Fibroid Clinical Program 11/5/2013
ARCA biopharma Announces IND Submission to FDA for Gencaro for the Treatment of Atrial Fibrillation 10/29/2013
Polaris Group Files New IND for ADI-PEG 20 in Breast Cancer 10/22/2013
RedHill Biopharma Ltd. (RDHL) Announces FDA Acceptance of IND Application for RHB-105 (H. pylori) Phase 3 Study - to Commence Shortly 10/22/2013
Discovery Laboratories (DSCO) Announces IND Submission for AEROSURF® 10/18/2013
Flatley Discovery Lab, LLC Nominates Clinical Candidate for Treatment of Cystic Fibrosis 10/11/2013
CFDA Accepts Sihuan Pharmaceutical Holdings Group Ltd. 's Application for Clinical Trial Approval for Self-Developed Innovative Oncology Drug Pirotinib 10/10/2013
StemCells Inc. (STEM) Receives FDA Authorization of IND for Spinal Cord Injury 10/2/2013
Advanced Cell Technology Files Investigational New Animal Drug (INAD) Application With FDA to Treat 10 Different Disease Indications Using Pluripotent Stem Cells 9/19/2013
GenKyoTex S.A. Receives FDA IND Approval for Phase II Clinical Study With First in Class NOX Inhibitor GKT137831 9/9/2013
International Stem Cell Corporation Advances Parkinson's Disease Program Towards IND Stage 9/9/2013
Oramed Pharmaceuticals Inc. (ORMP.OB) Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral GLP-1 Analog for the Treatment of Type 2 Diabetes 9/3/2013
Transdermal Delivery Solutions Subsidiary, Hormone Replacement Technologies, Receives FDA Approval to Begin Pivotal Clinical Trials of Testagen® TDS for the Treatment of Low Testosterone 8/22/2013
To-BBB technologies BV Receives IND Approval for Novel Brain Cancer Drug, 2B3-101 8/19/2013
Altor BioScience Corporation Launches Its Proprietary IL-15 Superagonist ALT-803 Into Clinical Trials Against Cancer 8/15/2013
GW Pharmaceuticals Opens an Investigational New Drug Application (IND) in the United States for a Sativex® Phase 3 Clinical Program as a Treatment for Spasticity Due to Multiple Sclerosis 8/14/2013
Atlantic Pharmaceuticals, Inc. Announces Successful Pre-IND Meeting With the FDA on Immediate Release, Abuse-Deterrent Hydrocodone 8/13/2013
Jubilant BioSys Ltd. Announces Successful Filing of Investigational New Drug With US-based Endo Pharmaceuticals (ENDP) 8/7/2013
ImmunoGen, Inc. (IMGN) Announces FDA Acceptance of IND for Company's Novel EGFR-Targeting ADC, IMGN289 8/2/2013
Oramed Pharmaceuticals Inc. (ORMP.OB) Submits Pre-IND Meeting Request to FDA for Its Oral Exenatide Capsule ORMD-0901 7/30/2013
PreScience Labs Announced that the FDA Accepts IND Application for Novel Oncology Drug 7/24/2013
Charleston Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting on New Migraine Treatment CL-H1T 7/23/2013
Kinex Pharmaceuticals Announces that the US FDA Allows their IND for Oraxol, an Oral Form of Paclitaxel That is in Phase II Clinical Trials in Korea, to Begin Clinical Trials in the US 7/22/2013
Genmab A/S (GEN.CO) Files IND for HuMax-TF-ADC 7/18/2013
Rexahn Pharmaceuticals, Inc. Announce IND Submission for RX-3117 7/15/2013
Pluristem Therapeutics (PSTI)'s South Korean Partner Files IND With Korean FDA for PLX Cells 7/8/2013
Astex Pharmaceuticals (ASTX) Announces IND Candidate: ASTX727 a Potential Best-in-Class Oral Hypomethylator 7/8/2013
Signum Dermalogix Investigational New Drug (IND) Application Cleared by FDA: SIG990 a Potential Treatment for Rosacea 7/8/2013
La Jolla Pharmaceutical Company (LJPC) Announces FDA Acceptance of IND for LJPC-501 7/2/2013
FDA Granted Fast Track Designation for Genervon's Breakthrough Biotechnology Multi-Target ALS Drug GM604 Expediting Drug Approval Process 6/27/2013
TherapeuticsMD, Inc. Investigational New Drug Filing Accepted by FDA 6/13/2013
FDA Accepts IND Application for Edge Therapeutics' EG-1962 (nimodipine microparticles) 6/10/2013
Bio-Matrix Scientific Group Inc. (BMSN.OB)'s Regen BioPharma Submits Response to FDA Questions Regarding HemaXellerate Clinical Program 6/7/2013
AVANIR Pharmaceuticals (AVNR) Announces Accelerated Development Path for AVP-786 Following Successful Pre-IND Meeting With FDA 6/5/2013
La Jolla Pharmaceutical Company (LJPC) Submits IND for LJPC-501 6/4/2013
Sunshine Biopharma, Inc. Announces That Its Breast Cancer Drug Candidate, Adva-27a, Also Destroys Pancreatic Cancer Cells 6/4/2013
Biovista and the CFIDS Association of America Achieve Drug Repositioning Milestone With Pre-IND Meeting 5/29/2013
Omeros Corporation (OMER) Release: Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease 5/23/2013
Perosphere Inc. Receives FDA IND Clearance to Initiate Clinical Investigations of the Safety and Efficacy of PER977 to Reverse the Activity of Anticoagulation Therapies Including Factor Xa- and IIa-Inhibitors 5/22/2013
Oramed Pharmaceuticals Inc. (ORMP.OB) Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S. 5/17/2013
Enanta Pharmaceuticals, Inc. Release: Breakthrough Therapy Designation From the FDA Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450 5/6/2013
RNL Bio Files IND to Commence Phase II Clinical Trial of RNL-JointStem for Osteoarthritis in the United States 5/2/2013