Oramed Pharmaceuticals Inc. (ORMP.OB) Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
5/17/2013
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Enanta Pharmaceuticals, Inc. Release: Breakthrough Therapy Designation From the FDA Granted to Investigational HCV Regimen Containing Protease Inhibitor ABT-450
5/6/2013
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RNL Bio Files IND to Commence Phase II Clinical Trial of RNL-JointStem for Osteoarthritis in the United States
5/2/2013
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R-Tech Ueno Receives FDA IND Approval for RU-101 (r-HSA) to Treat Severe Dry Eye
4/26/2013
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SK Bio-Pharmaceuticals Announces FDA's Authorization of IND for SKL15508
4/17/2013
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FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
4/16/2013
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Oramed Pharmaceuticals Inc. (ORMP.OB) Submits New IND Application for Oral Insulin Trial in the US
4/11/2013
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Boston Therapeutics, Inc. Requests an IND Meeting With the FDA for PAZ320 to Reduce Postprandial Hyperglycemia in Type 2 Diabetes
4/11/2013
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Lipid Therapeutics Successfully Files a U.S. IND for LT-02, a Novel Barrier Function Therapy for Ulcerative Colitis
4/10/2013
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ERYtech Pharma Receives FDA IND Clearance to Initiate a Clinical Study in Acute Lymphoblastic Leukemia in the U.S.
4/3/2013
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Cleveland Biolabs Inc. (CBLI) and Incuron Announce Notice of Allowance From FDA to Commence Clinical Testing With CBL0137
4/2/2013
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Soligenix (SNGX.OB) Receives IND Clearance From FDA to Initiate Clinical Program to Evaluate SGX942 for the Treatment of Oral Mucositis
3/27/2013
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Regen BioPharma Receives IND From FDA for HemaXellerate
3/18/2013
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Immunotech Laboratories in Discussions for Pre-"IND" Testing of Aids-HIV "IPF" Treatment in the USA
3/18/2013
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Sunshine Biopharma, Inc. Commences Negotiations With Contract Manufacturing Organizations for Production of Its Multidrug-Resistant Breast Cancer Drug, Adva-27a
3/14/2013
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La Jolla Pharmaceutical Company (LJPC) Announces FDA Agreement With Proposed IND Submission for LJPC-501 in Hepatorenal Syndrome
3/4/2013
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Sunshine Biopharma, Inc. Reports on IND Research for Its Novel Breast Cancer Drug Candidate, Adva-27a
2/26/2013
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Ampio Pharmaceuticals, Inc. (AMPE) Modifies Ampion™ IND for Osteoarthritis of the Knee to Include a Dose Escalation Run-In Study and Prepares to Launch Pivotal Clinical Trial
2/25/2013
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Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
2/14/2013
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FDA Agreement on Mesoblast Limited's Use of Singapore Manufacturing Facility for Clinical Trial Production of Proprietary Mesenchymal Precursor Cells
2/13/2013
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Regen BioPharma Files Investigational New Drug (IND) Application With FDA on HemaXellerate I™ Stem Cell Drug for Aplastic Anemia
2/5/2013
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Galectin Therapeutics Announces Submission of an Investigational New Drug (IND) Application for the Treatment of Fatty Liver Disease
1/31/2013
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ImmunoCellular Therapeutics, Ltd' Investigational New Drug (IND) Application for ICT-140 Allowed by the FDA
1/29/2013
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Regen BioPharma Peer-Reviewed Publication Provides Preclinical Support for HemaXellerate™ Bone Marrow Failure Product
1/25/2013
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PledPharma Release: FDA Has Approved IND Application for Clinical Trial With PledOx in the U.S.
1/22/2013
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Ampio Pharmaceuticals, Inc. (AMPE) Announces Active IND for Optina™ for the Treatment of Diabetic Macular Edema (DME)
1/22/2013
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Clearside Biomedical Announces Plans for Clinical Testing of CLS1001 (Triamcinolone Acetonide) Suprachoroidal Injectable Suspension for the Treatment of Some Eye Diseases
1/10/2013
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Soligenix (SNGX.OB) Receives IND Clearance From FDA to Initiate Program Evaluating OrbeShieldTM as a Therapy for Gastrointestinal Acute Radiation Syndrome
1/4/2013
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TG Therapeutics, Inc. (MHA) Announces FDA Clearance to Commence Clinical Trials of Its Novel, PI3K-Delta Specific Inhibitor, TGR-1202, Under Its Recently Filed U.S. Investigational New Drug (IND) Application
1/3/2013
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FDA Clears IND for First Clinical Trial Protocol Developed Using Crowdsourcing
12/18/2012
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Amarin Corporation PLC (AMRN) Announces Completion of Dosing in a Fixed-Dose Combination Study With Vascepa® and a Leading Statin
12/17/2012
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Invion Announces Successful Pre-Ind Meeting on INV103 (Cpn10) for the Treatment of Lupus
12/13/2012
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Results From Gentium S.p.A.'s Treatment IND for Defibrotide Presented at the American Society of Hematology Annual Meeting
12/13/2012
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Sunshine Biopharma, Inc. Completes Another IND-Enabling Study: Adva-27a is Found to be Effective Against Multidrug Resistant Uterine Cancer Cells
12/10/2012
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La Jolla Pharmaceutical Company (LJPC) Announces FDA Approval of IND
12/5/2012
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Sunshine Biopharma, Inc. Completes Six IND-Enabling Studies for Its Anticancer Compound, Adva-27a
12/4/2012
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Galapagos NV (GLPG.BR) Opens IND for GLPG0634 in the U.S.
12/3/2012
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Avaxia Biologics, Inc. Receives IND Clearance From FDA to Initiate Clinical Program to Evaluate AVX-470 as Therapy for Ulcerative Colitis
11/27/2012
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AtheroNova Inc. (AHRO.OB) Announces Milestone Filing of IND in Russian Federation
11/13/2012
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Hanmi Pharmaceutical, Co., Ltd and Kinex Pharmaceuticals Announced Korean FDA Allowance of the KX01 IND Application
11/7/2012
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TSRL, Inc. Reaches a Key Milestone With Pre-IND Meeting
10/26/2012
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TONIX Pharmaceuticals, Inc. Completes Pre-IND Meeting With FDA for Potential New Treatment for Post-Traumatic Stress Disorder
10/24/2012
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Avedro, Inc. Release: Keraflex® Keratoconus Treatment Study Begins in U.S.
10/12/2012
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Genesis Biopharma, Inc. Receives FDA Meeting Minutes From Contego™ Pre-IND Meeting
10/11/2012
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Sunshine Biopharma, Inc. Receives Scale-Up Manufacturing Protocol for Its Lead Anti-Cancer Compound, Adva-27a
10/9/2012
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Tesaro, Inc. Announces Clearance of Investigational New Drug Application for TSR-011
10/3/2012
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Investigational New Drug Application Cleared for Omeros Corporation (OMER)' Lead Compound in PDE10 Program
10/2/2012
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Synergy Pharmaceuticals Files IND for SP-333, a Developmental Drug for Gastrointestinal Diseases
9/12/2012
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Cold Genesys, Inc. Continuing Development of CG0070 Oncolytic Virus With GMCSF Expression
9/7/2012
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Omeros Corporation (OMER) Files Investigational New Drug Application for Lead Compound in PDE10 Program
9/6/2012
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Soligenix (SNGX.OB) Receives IND Clearance From FDA to Initiate Clinical Program to Evaluate SGX203 as Therapy for Pediatric Crohn's Disease
9/6/2012
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Invion Limited Release: Pre-Ind Meeting for Xtoll in Lupus Scheduled With FDA
9/5/2012
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Proacta Inc. Announces IND Allowance for PR610
8/29/2012
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Apexigen Announces the Filing of an IND by its Partner, 3SBio Inc. (SSRX)
8/16/2012
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Isconova's Adjuvant Matrix-M Approved by FDA for an IND Clinical Trial
8/15/2012
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Ferrer Submits IND for Arasertaconazole Nitrate, a Safe, Fast-Acting Topical Antifungal in Development for Vulvovaginal Candidiasis
8/7/2012
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Ampio Pharmaceuticals, Inc. (AMPE) Announces Successful Pre-IND Meeting With the Ophthalmology Division of the FDA on Optina™ for the Treatment of Diabetic Macular Edema
8/1/2012
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Camargo Pharmaceutical Services Fast Tracks 505(b)(2) Indian Products
7/24/2012
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pSivida Corp (PSDV) Receives FDA Clearance for Pivotal Trials for Injectable Sustained-Release Micro-Insert to Treat Uveitis
7/19/2012
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TherapeuticsMD, Inc. Announces Plans in Hormone Therapy That Concur With the Recent Joint Statement from NAMS, ASRM and The Endocrine Society
7/10/2012
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Capricor Announces FDA Approval to Initiate ALLSTAR Trial of Allogeneic Stem Cell Therapy in Patients Following Heart Attack
7/9/2012
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Ampio Pharmaceuticals, Inc. (AMPE) Reports Successful Type B Pre-IND Meeting with the FDA for Its Drug Zertane™ to Treat Premature Ejaculation (PE)
6/21/2012
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AVANIR Pharmaceuticals (AVNR) Announces FDA Acceptance Of IND For AVP-923 For The Treatment Of Agitation In Patients With Alzheimer's Disease
6/11/2012
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Arrowhead Research Corporation (ARWR) Advances ARC-520 into IND-Enabling Studies for the Treatment of Hepatitis B and Provides Guidance on Development Timeline
6/6/2012
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FivePrime Therapeutics, Inc. Announces That Human Genome Sciences Files U.S. IND for HGS1036/FP-1039 FGF Ligand Trap
6/4/2012
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RXi Pharmaceuticals (RXII) Receives FDA Clearance to Begin Clinical Trial With RXI-109
5/31/2012
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Soricimed Biopharma, Inc. Receives IND Clearance to Commence Phase I Trial of New Cancer Drug
5/30/2012
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Zogenix, Inc. Submits IND for Second DosePro(R) Candidate Relday(TM)
5/30/2012
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RetroSense Therapeutics Completes pre-IND Meeting for RST-001
5/24/2012
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Cellceutix (CTIX) Files Amended IND With FDA for Its Novel p53
5/21/2012
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Neuren Pharmaceuticals Limited Holds Pre-IND Meeting on Proposed Rett Syndrome Clinical Trials With FDA
5/17/2012
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Ambit Biosciences and Teva Pharmaceutical Industries Limited (TEVA) Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
5/17/2012
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TG Therapeutics, Inc. (MHA) Announces Investigational New Drug (IND) for TGTX-1101, Receives Clearance by the FDA to Commence Clinical Trials in the U.S.
5/15/2012
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Ampio Pharmaceuticals, Inc. (AMPE) Reports Pre-IND Meeting With the FDA to Obtain Clinical Path Guidance for Ampion™ for the Treatment of Chronic Pain of Osteoarthritis of the Knee and Schedules May 16th Webcast to Update Shareholders
5/11/2012
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Immunomic Therapeutics Receives IND Authorization for Phase I Study of JRC-LAMP-Vax Vaccine to Treat Japanese Red Cedar (Sugi) Allergy
5/4/2012
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Lixte Biotechnology Announces Submission of an IND to the FDA for Approval of a Clinical Trial of LB-100, a First-in-Class, Anti-Cancer Compound
5/1/2012
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Cleveland Biolabs Inc. (CBLI) and Incuron Announce Russian Regulatory Allowance of IND for Phase 1B Trial of CBLC137
4/30/2012
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Tengion Inc. Announces IND Filing for Neo-Kidney Augment Expected During First Half of 2013
4/18/2012
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Medgenics, Inc. Files IND Application for EPODURE Biopump Phase IIb Anemia Study in Dialysis Patients
4/17/2012
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ImmunoGen, Inc. (IMGN) Announces the IND Is Now Active for Its Folate-Receptor Targeting Anticancer Compound, IMGN853
4/17/2012
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FDA Schedules a Date With Cellceutix (CTIX) on New Psoriasis Drug
4/16/2012
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Cerecor Inc. Announces Clearance of IND for FP01
4/11/2012
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Marshall Edwards, Inc. (MSHL) Receives FDA Approval of Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344
4/10/2012
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Ampio Pharmaceuticals, Inc. (AMPE) Submits Pre-IND Package on Zertane to FDA
4/9/2012
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Frontage Laboratories Begins Early Phase Clinical Program for Hisun Pharma
4/4/2012
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Cannabis Science Inc. Continues Forward with FDA IND Process as Patients Report Successful Cancer Treatments
4/2/2012
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NanoViricides, Inc. (NNVC.PK) Announces Successful Pre-IND Meeting With the US FDA
4/2/2012
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Ablynx Receives Milestone Payment as Collaborator Receives IND Approval for a Nanobody in Oncology
4/2/2012
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Tengion Inc. Announces Significant Advances in Neo-Urinary Conduit(TM) and Neo-Kidney Augment(TM) Programs
3/27/2012
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FDA Accepts PaxVax, Inc.’s IND for Single-Dose Oral Cholera Vaccine
3/19/2012
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Cellceutix (CTIX) Files Pre-IND Documentation to FDA for New Psoriasis Drug
3/12/2012
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Cannabis Science Inc. Confirms Target Indication for FDA and Prepares for Pre-IND Meeting with the FDA with its Team of FDA Specialists
3/12/2012
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Viral Genetics Inc. (VRAL) Submits Pre-IND Document for Lyme Disease Drug Candidate to FDA
3/7/2012
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NanoViricides, Inc. (NNVC.PK) Announces US FDA has Confirmed Pre-IND Meeting Date
3/5/2012
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Tau Therapeutics, LLC IND Accepted by FDA for Novel Cancer Drug
2/28/2012
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S1 Pharmaceuticals, Inc. Announces IND Filing of SIP-104 (Lorexys) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
2/21/2012
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Coronado Biosciences Announces IND Submission for CNDO-109 for the Treatment of Relapsed Acute Myeloid Leukemia
2/14/2012
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Neurelis Announces FDA Allowance of IND Application for NRL-1, a Novel Intranasal Diazepam Formulation
2/7/2012
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ZIOPHARM, Inc. Announces FDA Acceptance of IND for Oral Palifosfamide
2/6/2012
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OptiNose AS Files Investigational New Drug Application to use Sumatriptan Delivered with its Novel Drug Delivery Technology
2/3/2012
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NanoViricides, Inc. (NNVC.PK) Submits Pre-IND Briefing Document for its Anti-Influenza Drug, FluCide™, to the US FDA
1/31/2012
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Cancer Patient Success Prompts Cannabis Science Inc. to Begin FDA Investigational New Drug (IND) Application Process
1/25/2012
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FDA Grants Orphan Drug Designation to Ikaria Inc. For Use of Inhaled Nitric Oxide in Pulmonary Arterial Hypertension
1/24/2012
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Avila Therapeutics Announces FDA Allowance of Partner Clovis Oncology (CLVS)’s IND Application for CO-1686, an Oral EGFR Mutant-Selective Inhibitor, Triggers $4 Million Milestone Payment to Avila
1/20/2012
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Repros Therapeutics Inc. (RPRX)' IND for Proellex(R)-V Accepted By the FDA
1/5/2012
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FDA Approval to Commence Huntington's Disease Clinical Trial Using PRANA Biotechnology (PRAN)'s PBT2
1/4/2012
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Arrowhead Research Corporation (ARWR) Announces FDA Clearance to Initiate AdipotideTM Phase I Clinical Trial
1/4/2012
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BioMarin Pharmaceutical Inc. (BMRN) Announces IND for BMN-111 for Achondroplasia is Active
1/3/2012
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Phage Pharmaceuticals (Formerly Known as Phage Biotechnology Corp.) to File Investigational New Drug (IND) Application Using Its Lead Drug Candidate, FGF-1, for a First-in-Class Indication to Repair Tympanic Membrane Perforations
12/21/2011
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Oncothyreon Files Investigational New Drug Application for ONT-10
12/20/2011
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FDA Agrees With AtheroNova Inc. (AHRO.OB)'s Clinical Development Plan as Proposed
12/15/2011
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ContraFect Corporation Completes Successful Pre-IND Meeting With FDA
12/14/2011
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Results From Gentium S.p.A.'s Treatment IND for Defibrotide Presented at the American Society of Hematology Annual Meeting
12/13/2011
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NanoViricides, Inc. (NNVC.PK) Announces That It Has Submitted a Pre-IND Meeting Request to the US FDA For Its Anti-Influenza Clinical Drug Candidate, FluCide™
12/5/2011
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Spectrum Pharmaceuticals, Inc. (SPPI) Files IND Application with U.S. FDA for SPI-014
12/5/2011
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AEterna Zentaris (AEZS): FDA Grants IND to Investigator at Baylor College of Medicine for Phase 2A Trial with AEZS-130 in Cancer Cachexia
11/28/2011
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Advaxis, Inc. Completes Pre-IND Meeting for ADXS-HER2
11/23/2011
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Apricus Biosciences (APRI) Announces That Its NexACT(R) Partner Exodos Life Sciences Has Completed Its pre-IND Meeting With the FDA
11/15/2011
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Vanton Research Laboratory's Infusion Delivery System for an Oncologic NCE Will Proceed with IND
11/15/2011
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Clinical Hold Removed for Helix Biopharma (CC:HBP)'s Topical Interferon Alpha-2b Phase II/III Efficacy Trial IND Application
11/11/2011
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Cellceutix Files Investigational New Drug Application (IND) With FDA, Clinical Trials Planned at Dana-Farber Cancer Institute/Harvard Cancer Center
11/7/2011
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Circadian Technologies Limited (CIR.AX) Receives FDA IND Approval to Begin Clinical Trials With VGX-100 for the Treatment of Cancer Patients With Solid Tumors
10/31/2011
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AtheroNova Inc. (AHRO.OB) Completes Successful Pre-IND Meeting with FDA on AHRO-001
10/26/2011
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AEterna Zentaris (AEZS): FDA Grants IND to Investigator at University of Miami School of Medicine for Phase 2 Trial with AEZS-108 in Triple-Negative Breast Cancer
10/25/2011
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AEterna Zentaris (AEZS): FDA Grants IND to Investigator at University of Miami School of Medicine for Phase 2 Trial with AEZS-108 in Triple-Negative Breast Cancer
10/25/2011
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Cleveland Biolabs Inc. (CBLI) Announces Opening of New IND for CBLB502 in Cancer Patients
10/19/2011
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Oxford BioMedica PLC (OXB.L) Announces US IND Approval for Novel Ocular Product in Usher Syndrome Type 1B
10/18/2011
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Helix Biopharma (CC:HBP) Files IND Clinical Hold Response With FDA for Its Planned Topical Interferon Alpha-2b Phase II/III Efficacy Trial
10/13/2011
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Advaxis, Inc. Granted Pre-IND Meeting with FDA for ADXS-HER2, an Immunotherapy for HER2 Expressing Cancers
10/11/2011
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Circadian Technologies Limited (CIR.AX) Files IND With FDA for VGX-100 for the Treatment of Cancer Patients With Solid Tumors
9/30/2011
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CorMedix (CRMD) Announces FDA Designation for Neutrolin (CRMD003)
9/29/2011
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ImmunoGen, Inc. (IMGN) Announces Submission of IND for Wholly Owned Product Candidate for Non-Hodgkin's Lymphoma
9/23/2011
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AB Science (AB.PA) Announces That FDA Authorization (IND) Has Been Granted for the Initiation of Its Phase 3 Study in Severe Asthma. Patient Recruitment Commences in the US
9/14/2011
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pSivida Corp (PSDV) Announces Opening of Investigator-Sponsored Trial for Injectable, Sustained Release FAc Insert for Posterior Uveitis
9/12/2011
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Repros Therapeutics Inc. (RPRX) to Submit IND for Vaginal Delivery of Proellex(R) for Fibroid De-bulking and Symptom Elimination
9/9/2011
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Sagene Pharmaceuticals, Inc. Completes Successful Pre-IND Meeting with FDA for Dual-Action Erectile Dysfunction Drug
9/9/2011
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KFDA Grants D-Pharm Ltd. IND Approval for Phase III MACSI Study of DP-b99 in Korea
8/24/2011
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Pfizer Inc. (PFE) Announces European Medicines Agency Acceptance of Regulatory Submissions For Two Investigational Cancer Therapies
8/17/2011
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Marshall Edwards, Inc. (MSHL) Announces FDA Approval of Investigational New Drug Application for Lead Candidate ME-143
8/16/2011
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Advaxis, Inc. Completes Pre-IND Meeting for ADXS-PSA
8/11/2011
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NanoViricides, Inc. (NNVC.PK) Reports That It is Financially Sound and is Progressing Towards Initial FDA Submission
8/8/2011
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Femta Pharmaceuticals Announces IND Filing of FM101, a Novel Monoclonal Antibody Targeting IL-6 with Potent Anti-Inflammatory Activity
8/1/2011
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With Contracts and IND Application in Hand, Cellceutix Nears Clinical Trials for New Cancer Drug
8/1/2011
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FDA Clears 22nd Century Group, Inc.'s X-22 IND For Phase II-B Smoking Cessation Clinical Trial
7/22/2011
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Newron Pharmaceuticals (NWRN) Submits US IND for NW-3509, a Potential Add-On Treatment for Patients with Schizophrenia
7/13/2011
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Alnylam Pharmaceuticals (ALNY) Files Clinical Trial Application (CTA) for ALN-PCS, an RNAi Therapeutic Targeting PCSK9 for the Treatment of Severe Hypercholesterolemia
7/11/2011
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MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) Licensee RenovoCyte LLC Receives FDA INAD for Universal Donor Endometrial Regenerative Cells (ERC)
7/1/2011
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Advaxis, Inc. Granted Pre-IND Meeting with the FDA for Advaxis-PSA Prostate Immunotherapy
6/30/2011
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Nuvo Research Inc. (NRI.TO) Receives IND Clearance From FDA to Begin Clinical Testing of Lidocaine Spray
6/29/2011
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Ventrus Biosciences, Inc. (VTUS) Receives SPA Response From FDA and Will Update and File the First Pivotal Trial Protocol to its IND
6/22/2011
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22nd Century Group, Inc. Files Investigational New Drug Application and Fast Track Request for X-22; Phase II-B Clinical Trial to Commence Immediately Upon FDA Clearance
6/22/2011
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FDA Lifts Hold on Senesco Technologies, Inc. (SNT)'s Lead Drug Candidate
6/21/2011
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ZIOPHARM Oncology, Inc. (ZIOP.OB) Announces Acceptance of Investigational New Drug Application for ZIN ATI-001 (Ad-RTS-IL-12), a Novel DNA-Based Oncology Therapeutic Candidate
6/10/2011
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FDA Approves Trial of Adamis Pharmaceuticals Product Candidate to Treat Prostate Cancer
6/8/2011
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NovaDel Pharma (NVD) Reports Opening of Duromist(TM) Original IND with FDA
6/2/2011
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FDA Approves Trial of Pathway Therapeutics Limited Cancer Drug; $7.5 Million Financing in Place to Advance Novel PI3K/mTOR Inhibitor Portfolio
5/25/2011
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ZIOPHARM Oncology, Inc. (ZIOP.OB) Files Investigational New Drug Application for Ad-RTS-IL-12, a Novel DNA-Based Oncology Therapeutic Candidate
5/13/2011
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Allergy Therapeutics plc Release: FDA Confirms Clinical Hold Will be Lifted on all Three INDs for Pollinex Quattro Products
4/26/2011
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AVANIR Pharmaceuticals (AVNR) Announces Filing of IND for AVP-923 for the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis
4/4/2011
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Insmed Incorporated (INSM) Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE(TM) in Nontuberculous Mycobacteria Indication
3/21/2011
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Oxford BioMedica PLC (OXB.L) Announces US IND Approval for Novel Ocular Product in Stargardt Disease
3/21/2011
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Senesco Technologies, Inc. (SNT)’s Lead Therapeutic Candidate SNS01-T Waiting for Update to Vendor’s Drug Master File
3/11/2011
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Apexigen Announces the Filing by its Partner, Simcere Pharmaceutical Group, of First IND
3/11/2011
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Neoprobe Corporation (NEOP) Completes Successful Pre-IND Meeting with FDA on RIGScan CR
3/7/2011
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FDA Clears Palatin Technologies (PTN)' IND Filing to Commence Clinical Studies for Asthma
3/3/2011
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Bayhill Therapeutics, Inc. Announces the Successful Clearance of an IND for BHT-3034 for the Treatment of Myasthenia Gravis
3/2/2011
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BioDelivery Sciences International (BDSI) Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
3/2/2011
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Generex Biotechnology Corporation (GNBT) Announces New Treatment IND Site for the US FDA Expanded Access Treatment IND Program for Generex Oral-lyn(TM) in the United States
2/23/2011
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CeNeRx BioPharma, Inc. Announces FDA IND Approval for its Neuroprotective Agent in Chemotherapy-Induced Neuropathy and Results From First Human Study
2/9/2011
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Helix Biopharma (CC:HBP) Receives FDA IND Approval to Conduct a U.S. Phase I Clinical Study With Its Lung Cancer Drug Candidate L-DOS47
2/7/2011
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MorphoSys AG Reaches Clinical Milestone with Pfizer Inc. (PFE)
1/31/2011
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Senesco Technologies, Inc. (SNT) Announces IND Filing with FDA for SNS01-T
1/24/2011
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InSite Vision (ISV) Files IND for ISV-101 with the U.S. FDA for the Treatment of Dry Eye Disease
1/11/2011
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Helix Biopharma (CC:HBP) Files IND for a U.S. Phase I Clinical Study of Its Cancer Drug Candidate L-DOS47
1/7/2011
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Advanced Cell Technology Receives FDA Clearance For Clinical Trials Using Embryonic Stem Cells to Treat Age-Related Macular Degeneration
1/3/2011
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MP Biomedicals, Inc. Receives IND Approval to Commence Clinical Trials for Its HTLV-I/II Screening and Confirmatory Tests
12/7/2010
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iBio, Inc. (IBPM) Release: Another Clinical Trial Commenced for a Product Based on iBioLaunch Technology
12/6/2010
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Sequella, Inc. Files IND and Receives FDA Go-ahead for Phase 2 Trial of SQ109 in Helicobacter pylori-associated Duodenal Ulcers
12/6/2010
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APR Applied Pharma Research S.A. and Labtec GmbH Announce Filing for Approval in Europe of Zolmitriptan Oral Dispersible Film (ODF)
12/2/2010
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QR Pharma Receives FDA Clearance to Conduct Clinical Trials with Its Second Novel Alzheimer Compound, Bisnorcymserine
12/2/2010
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California Stem Cell, Inc. Files IND to Commence Phase I Clinical Trial in Spinal Muscular Atrophy
12/1/2010
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Auris Medical AG Receives IND Approval from FDA to Start Clinical Trial With AM-101
11/24/2010
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PolyMedix Inc. (PYMX.OB) Obtains Regulatory Clearance for its United States IND Application for PMX-30063 Antibiotic
11/10/2010
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Oxford BioMedica PLC (OXB.L) Announces US IND Approval for Novel Ocular Product in Wet AMD
11/9/2010
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GeNO LLC Submits Investigational New Drug Application for Its NITROsyl(TM) Inhaled Nitric Oxide System to Treat Chronic Pulmonary Hypertension
11/2/2010
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Cellceutix Completes Final Toxicity Study for Its Cancer Compound; United States FDA IND Application Underway
10/28/2010
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Helix Biopharma (CC:HBP) Files IND for Its Planned Phase II/III Efficacy Trial of Topical Interferon Alpha-2b in Patients With Low-Grade Cervical Lesions
10/19/2010
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STB Lifesaving Technologies: Successful Pre-IND FDA Filing for STB's FAST(R) Dressing Propels Lifesaving Technology Forward
10/18/2010
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Apricus Biosciences (APRI) Announces IND Filing for Nupen(TM), Its Proprietary Topical Neupogen(R) Formulation Containing NexACT(R)
10/14/2010
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Accera, Inc. Appoints Dr. Thomas Werner President & CEO and Announces FDA Acceptance of IND Application for AC-1204 for Mild-to-Moderate Alzheimer's Disease
10/5/2010
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Amira Pharmaceuticals, Inc. Announces IND Submission for Novel LPA1 Antagonist, AM152, for Potential Use in Fibrotic Diseases
9/28/2010
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Cytonet GmbH & Co. KG Release: FDA Approves Innovative Liver Cell Therapy for Clinical Trial in the U.S.
8/10/2010
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CureMark IND for ADHD Granted by FDA
8/10/2010
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Tekmira Pharmaceuticals Corporation Files IND Application With U.S. FDA for PLK1 SNALP
8/5/2010
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Affymax, Inc. (AFFY) and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Announce Preliminary U.S. Registration Strategy for Investigational Drug, Hematide(TM)/Peginesatide, to Treat Anemia in Chronic Renal Failure
8/5/2010
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ANTISENSE PHARMA GmbH Obtains IND for Clinical Studies in the USA
8/3/2010
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Fera Pharmaceuticals Strengthens Product Pipeline with Acquisition of Investigational New Drug
7/21/2010
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HanAll BioPharma Co., Ltd. (009420.KS) Release: U.S. IND Accepted by the FDA in Support of the Clinical Development HL 007, a Unique Fixed Dose Combination to Treat Cardiovascular Disease
7/12/2010
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Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States
7/8/2010
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FDA Approves Beech Tree Labs, Inc.'s Oral Herpes IND Application
7/7/2010
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