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Clinical - IND
TrovaGene (TROV) Announces Submission Of Investigational New Drug Application To Initiate Phase Ib/II Clinical Trial Of PCM-075 For Acute Myeloid Leukemia 6/27/2017
KaloBios (KBIO) Release: Benznidazole IND For Chagas Disease Receives Clearance By FDA 6/27/2017
Proteostasis (PTI) Files Investigational New Drug Application For PTI-808, Cystic Fibrosis Potentiator 6/23/2017
Seattle Genetics (SGEN) Takes Another Hit as the FDA Slaps Hold on IND for Vadastuximab Talirine 6/23/2017
OncoArendi Therapeutics SA Announces Selection Of Its Second Clinical Development Candidate: OATD-02 For The Treatment Of Multiple Cancers 6/21/2017
Unum Announces Active Investigational New Drug (IND) Application For ACTR707 In Combination With Rituximab In Patients With Relapsed/Refractory B-Cell Lymphoma 6/19/2017
Cerveau Technologies Announces FDA Acceptance Of Investigational New Drug (IND) For Tau Imaging Agent MK-6240 6/16/2017
AGTC (AGTC) Release: IND-Enabling Study Data Published In Human Gene Therapy Clinical Development Support Clinical Development Of AGTC-402 For The Treatment Of CNGA3-Deficient Achromatopsia 6/15/2017
Moleculin Biotech (MBRX) Announces Preparation To File An IND With The f-Star For WP1220 For Treatment Of Cutaneous T-Cell Lymphoma 6/13/2017
2X Oncology Obtains Investigational New Drug Application For 2X-111 Glutathione Enhanced PEGylated Liposomal Doxorubicin 6/8/2017
Verona Pharma (VRP.L) Initiates U.S. Clinical Pharmacokinetic Study For RPL554 Following Acceptance Of IND Application By FDA 6/5/2017
Aduro Biotech (ADRO) Announces FDA Clearance Of Investigational New Drug Application To Evaluate The Combination Of ADU-S100 With PDR001 For The Treatment Of Solid Tumors And Lymphomas 6/1/2017
Athenex And Its Partner, Guangzhou Xiangxue Pharma, Announced Chinese FDA IND Approval To Begin Clinical Trials Of KX-02 Tablet For Glioblastoma 5/25/2017
ViaCyte Receives IND Allowance From FDA And Clearance From Health Canada To Commence International Clinical Trial Of PEC-Direct Cell Therapy For High-Risk Type 1 Diabetes 5/22/2017
Recce (RCE) Moves Closer To Clinical Study Application With Additional Data On Its Novel Antibiotic 5/19/2017
Kemwell Biopharma Supplies Biologics Drug Substance For Phase l Clinical Trials For U.S. IND Filing 5/17/2017
Sangamo (SGMO) Receives Fast Track Designation From The FDA For SB-525 Investigational Hemophilia A Gene Therapy 5/16/2017
Editas Medicine (EDIT) Delays IND for Lead CRISPR Candidate 5/16/2017
NantKwest And NantCell Announce FDA Authorization For The NANT Cancer Vaccine Clinical Trials, The First Novel Combination Of Innate And Adaptive Immunotherapy In Patients With Pancreatic Cancer 5/9/2017
Protalix (PLX) Announces FDA Investigational New Drug Clearance To Commence Once-Monthly Dosing Study Of Pegunigalsidase Alfa (PRX-102) For The Treatment Of Fabry Disease 5/9/2017
PharmaCyte (PMCB) Updates IND Submission Process In Interview With Facet Life Sciences 5/8/2017
Cellect (APOP) Gets Green Light From FDA For Apograft IND Submission In The U.S. 5/3/2017
EndoLogic Announces Scheduling Of Pre-IND Meeting With FDA To Discuss Renzapride In Diabetic Gastroparesis 5/3/2017
Eiger Biopharma Announces U.S. IND Filing Of Pegylated Interferon Lambda For Hepatitis Delta Virus Infection 5/3/2017
IMPACT Received IMP4297 Chinese IND Approval 5/3/2017
ZIOPHARM Oncology (ZIOP) Announces FDA Acceptance Of IND For CD33-Specific CAR-T Cell Therapy Targeting Relapsed/Refractory Acute Myeloid Leukemia 5/2/2017
Tesaro (TSRO) Announces Submission Of Investigational New Drug Application For Anti-LAG Antibody TSR-033 To The FDA 5/1/2017
Sirnaomics Received IND Approval From CFDA For Its Leading siRNA Therapeutic Candidate, STP705, For Treatment Of Hypertrophic Scar 5/1/2017
Medeor Receives FDA Clearance Of IND Application And Special Protocol Assessment For Pivotal Clinical Study Of MDR-101 4/28/2017
ProQR Therapeutics B.V. (PRQR) Announces Clearance Of IND Application To Start Clinical Trial For QR-110 In Leber’s Congenital Amaurosis Type 10 Patients 4/27/2017
Antibe Therapeutics (ATE.V) Advances Development Of ATB-352 In Wake Of Growing Global Opioid Epidemic 4/26/2017
Glenmark Pharma Initiates Clinical Investigation For GBR 310, Its Proposed Biosimilar Candidate For XOLAIR 4/25/2017
Syros Pharma Announces FDA Acceptance Of IND To Advance SY-1365, Its First-In-Class Selective CDK7 Inhibitor, Into Phase I Clinical Trial In Patients With Advanced Solid Tumors 4/10/2017
KaloBios (KBIO) Release: Benznidazole On Track In Progress To IND And NDA Submissions 4/6/2017
SRI International Receives U.S. FDA Clearance For Investigational New Drug Application Evaluating Novel Oral Treatment To Combat Radiation Exposure 3/31/2017
Athenex Announces The U.S. FDA Allowance Of The Investigational New Drug Application Of Oratopo, A Combination Of HM30181A And Oral Topotecan For The Treatment Of Advanced Cancer 3/29/2017
Ligand (LGND) Announces Licensing Partner Janssen Pharmaceutical Has Filed An IND For An Antibody Discovered Using The OmniAb Technology 3/28/2017
Catalyst Biosciences Announces IND Approval In South Korea For Next-Generation Subcutaneous Factor IX Program 3/28/2017
Tarrex Biopharma Inc. Announces FDA Acceptance Of IND Application For TX803 To Commence Phase I Clinical Trials In Colorectal Cancer Patients 3/21/2017
Asana Biosciences Announces FDA Acceptance Of The IND Application For Its Novel SYK-JAK Inhibitor For Evaluation In Atopic Dermatitis 3/16/2017
Servier And Pfizer (PFE) Announce FDA Clearance Of IND Application For UCART19 In Adult Relapsed/Refractory Acute Lymphoblastic Leukemia 3/9/2017
Glenmark Pharma Receives FDA Clearance Of IND For GSP 304 3/7/2017
Advaxis (ADXS) Announces FDA Acceptance Of IND For Groundbreaking Personalized Neoepitope Immunotherapy, ADXS-NEO 3/6/2017
MabVax Therapeutics Studies Lead Investigational Drug MVT-5873 With Halozyme (HALO) PEGPH20 2/13/2017
FDA Grants Cellectis (ALCLS) IND Approval To Proceed With The Clinical Development Of UCART123, The First Gene Edited Off-The-Shelf CAR T-Cell Product Candidate Developed In The U.S. 2/7/2017
Alcobra (ADHD) Reports On Productive FDA Meeting For New Lead Product Candidate For ADHD 2/7/2017
Aura Biosciences Receives FDA Clearance Of Investigational New Drug Application For Light-Activated AU-011 For The Treatment Of Ocular Melanoma 2/6/2017
Audentes (BOLD) Announces FDA Clearance Of Investigational New Drug Application For AT342 To Treat Crigler-Najjar Syndrome 2/1/2017
Relmada Therapeutics Release: Announces FDA Acceptance Of IND And Authorization To Commence Phase 2a Clinical Trial For D-Methadone 1/26/2017
BeyondSpring Pharmaceuticals Release: FDA Accepts Company IND Application For Plinabulin For The Prevention Of Chemotherapy-Induced Neutropenia 1/24/2017
Vectura (VEC.L) Release: FDA Approves IND To Support Company’s Wholly-Owned Programme VR647 In Paediatric Asthma 1/24/2017
Isofol Medical AB Release: FDA Clears Company’s IND Application To Start Clinical Program Within Colorectal Cancer With Modufolin 1/24/2017
WuXi AppTec Release: Novel Anti-IL-6 Antibody For Rheumatoid Arthritis From WuXi-MedImmune (AZN) Joint Venture Receives Clinical Trial Permit (CTP) From CFDA 1/18/2017
MabVax Therapeutics Files Investigational New Drug Application For Novel Radioimmunotherapy Agent MVT-1075 1/9/2017
Sangamo (SGMO) Announces FDA Clearance Of Investigational New Drug Application For SB-525 Gene Therapy Program For Hemophilia A 1/5/2017
NeuroRx Announces FDA IND Clearance For NRX-101 Phase 2b/3 Study And Publication Of Promising Biomarker Data 1/4/2017
Kura Oncology Receives FDA Clearance To Proceed With Clinical Trial For ERK Inhibitor KO-947 And Nominates KO-539 As Development Candidate For Menin-MLL Inhibitor Program 1/4/2017
Cellectis (ALCLS) Submits IND Application For UCART123, An Allogeneic Gene Edited CAR T-Cell Product Candidate, In AML And BPDCN 1/4/2017
Glenmark Pharma Receives FDA Clearance Of IND For GBR 1302-BEAT Phase I Trial 1/3/2017
Axsome (AXSM) Receives FDA Clearance Of IND For Phase II/III Trial Of AXS-05 In Alzheimer’s Disease Agitation 1/3/2017
Akari Therapeutics Announces FDA Allowance Of IND For Clinical Development Of Coversin In PNH 1/3/2017
Kite Pharma (KITE) Submits Investigational New Drug (IND) Application For KITE-718, An Investigational Next Generation T-Cell Receptor (TCR) Therapy Targeting Cancer Antigens MAGE A3 And MAGE A6 1/3/2017
Ascentage Pharma's Cancer Drug Candidate Advances Toward US/China Trials 12/27/2016
Zomedica Opens Investigational New Animal Drug Application With FDA Center For Veterinary Medicine For Anti-Diarrheal Medication ZM-007 12/19/2016
Amunix, Inc. Release: IND Submission To Initiate Clinical Trials Of NB 1001 (XTEN-GLP1) For Treatment Of Short Bowel Syndrome Announced By Naia Rare Diseases 12/19/2016
Cambridge Biotech Agios (AGIO) Terminates AG-519 for PK Deficiency, But Continues AG-348 For Same Condition 12/19/2016
Cerenis Therapeutics, Inc. Receives FDA IND Approval To Begin Studies With CER-209 In NAFLD And NASH 12/16/2016
CytomX Announces U.S. FDA Clearance Of Investigational New Drug Application For Phase I/II Clinical Study Of Anti-PD-L1 Probody Therapeutic, CX-072 12/14/2016
AnaptysBio Announces Clearance Of U.S. IND And U.K. CTA For ANB020 12/13/2016
UroGen Announces FDA Acceptance Of Investigational New Drug Application For Mitogel, A Novel Sustained Release Formulation Of Mitomycin C, For The Treatment Of Low-Grade Upper Tract Urothelial Carcinoma 12/12/2016
3D Medicines (Sichuan) Co., Ltd. And Suzhou Alphamab Co., Ltd. Release: Global First IND For Subcutaneous Injectable Anti-PD-L1 Domain Antibody Receives FDA Approval 11/30/2016
Portfolio Company TopiVert Receives IND Approval For TOP1630 In The Treatment Of Dry Eye Syndrome 11/28/2016
Moleculin Announces Positive FDA Guidance Regarding Annamycin IND 11/17/2016
TLC Announces Approval Of The TLC178 Investigational New Drug Application By TFDA 11/16/2016
Regenicin, Inc. Completes Successful Pre-IND Meeting With FDA For Its New Autologous Cultured Skin Substitute, NovaDerm 11/2/2016
Mersana Announces FDA Clearance Of IND Application For Lead Antibody-Drug Conjugate XMT-1522 10/24/2016
AGTC (AGTC) Files Investigational New Drug Application For The Treatment Of Achromatopsia Caused By Mutations In The CNGA3 Gene 10/20/2016
CFDA Accepts CStone Pharma's IND Submission For PD-L1 Candidate 10/20/2016
CStone Pharma' PD-L1 Monoclonal Antibody IND Has Been Formally Accepted By The CFDA 10/18/2016
Athenex Announces Xiangxue Pharmaceutical, Its KX-02 Development Partner In China, Has Achieved A Regulatory Milestone In That Territory 10/18/2016
VBI Vaccines Completes Pre-IND Meeting For Its Glioblastoma Immunotherapy Candidate 10/12/2016
Panther Biotechnology Requests Pre-IND Meeting With FDA 10/11/2016
Velicept Therapeutics Announces FDA Acceptance Of IND Application Of Novel, Once-Daily Formulation Of Solabegron For The Treatment Of Overactive Bladder 10/5/2016
Asana Biosciences Announces Acceptance Of Its Third IND Application In Oncology 10/4/2016
GENFIT (ALGFT) Is Filing For IND Submission For New Indication Of Elafibranor In Primary Biliary Cholangitis (PBC) 9/28/2016
Regen BioPharma Responds To FDA On dCellVax Gene-Silenced Breast Cancer Immunotherapy 9/15/2016
Novogen Limited (NVGN) Release: US FDA Approves Investigational New Drug (IND) Application For Cantrixil(TM) (TRX-E-002-1) In Ovarian Cancer 9/12/2016
Cytokinetics (CYTK) Announces Next-Generation Fast Skeletal Muscle Activator Entering IND-Enabling Studies 9/8/2016
FDA Allows Phrixus Pharmaceuticals' IND For Carmeseal-MD (P-188 NF) In Duchenne Muscular Dystrophy (DMD) 9/7/2016
CTD Holdings Announces FDA Acceptance Of Investigational New Drug Application For Treatment Of NPC With Trappsol Cyclo 9/6/2016
Synlogic Proprietary Synthetic Biotic Receives FDA Orphan Drug Designation 8/29/2016
Mallinckrodt (MNK) Receives FDA Fast-Track Designation For Synacthen Depot IND Application 8/25/2016
DeuteRx Enters Clinical Stage Development With DRX-065 8/22/2016
Xenetic Biosciences Announces FDA Acceptance Of Investigational New Drug Application To Initiate Phase II Clinical Trial Of Virexxa In Endometrial Cancer 8/19/2016
Zymeworks Receives FDA Acceptance Of IND Application For ZW25, A Novel Bi-Specific Antibody, For The Treatment Of HER2-Expressing Cancers 8/18/2016
Novogen Limited (NVGN) Submits Investigational New Drug (IND) Application To The US FDA For Cantrixil In Ovarian Cancer 8/11/2016
Amphivena Therapeutics Announces Acceptance Of Investigational New Drug (IND) Application For AMV564 And Planned Phase 1 Trial Initiation 8/10/2016
CTD Holdings Files Investigational New Drug Application With U.S. FDA To Further Advance Its Drug Development Program 8/8/2016
Neon Therapeutics Announces FDA Acceptance Of Investigational New Drug Application For Cancer Vaccine NEO-PV-01 7/29/2016
AbbVie (ABBV) Receives U.S. FDA Rare Pediatric Disease Designation For Investigational ABT-414 For The Treatment Of A Type Of Pediatric Brain Tumor Known As Diffuse Intrinsic Pontine Glioma (DIPG) 7/11/2016
Eleven Bio (EBIO) Announces Effectiveness Of Investigational New Drug Application For EBI-031 7/8/2016
FDA Clears Biohaven's Investigational New Drug Application For BHV-4157 And Portage Biotech To Hold Investor Conference Call To Provide Business Update 7/5/2016
GeoVax Labs Inc. (GOVX.OB) Announces Filing Of Investigational New Drug Application For HIV Human Clinical Trial 6/30/2016
Regulus (RGLS) Shares Crumble As FDA Puts Hep C Treatment on Hold 6/28/2016
Sangamo (SGMO) Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS II 6/20/2016
Unum Announces Active Investigational New Drug (IND) Application For ACTR087 In Patients With Relapsed/Refractory B-Cell Lymphoma 6/20/2016
NLS Pharma Release: FDA Accepts IND For Phase II Study Of Mazindol In Adults With ADHD 6/16/2016
AEterna Zentaris (AEZS) Announces IND Submission By Sinopharm A-Think 6/15/2016
Eleven Bio (EBIO) Announces Investigational New Drug Application Submission To Initiate Clinical Trials Of EBI-031 For Ocular Diseases 6/13/2016
Mallinckrodt (MNK) Submits Investigational New Drug Application For Synacthen Depot 6/13/2016
Arrien Pharmaceuticals LLC Initiated Phase I Clinical Trials Of ARN-6039 As A New Agent For Treatment Of Multiple Sclerosis (MS) 6/3/2016
Curis (CRIS) Announces FDA Acceptance Of Investigational New Drug Application For CA-170, The First Orally Available Small Molecule To Target And Inhibit Immune Checkpoints 6/1/2016
Syros Pharmaceuticals Announces FDA Acceptance Of IND To Advance SY-1425 Into Phase II Clinical Trial 5/31/2016
AmpliPhi Bio (APHB) Announces Start Of First Phage Therapy Trial In U.S. Under IND 5/24/2016
FDA Grants IND Approval To Stemedica Cell Technologies, Inc. For A Traumatic Brain Injury Phase Ila Clinical Trial 5/18/2016
Newron Pharma (NWRN) Announces IND Approval For Sarizotan For Treatment Of Rett Syndrome 5/17/2016
NLS Pharma Announces Submission Of Investigational New Drug (IND) Application To FDA For Its Controlled-Release Mazindol For The Treatment Of Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) 5/12/2016
H3 Biomedicine Receives FDA Acceptance For Investigational New Drug Application 5/11/2016
Zomedica Opens First Investigational New Animal Drug Application With FDA Center For Veterinary Medicine 5/10/2016
Nordic Nanovector Announces An Open Investigational New Drug Application For New Clinical Study Of Betalutin In Diffuse Large B-Cell Lymphoma 5/9/2016
Epizyme (EPZM) Announces FDA Acceptance Of Investigational New Drug Application For Tazemetostat In Mesothelioma 5/4/2016
Corium International, Inc. Announces Streamlined Bioequivalence Development Path For Transdermal Corplex Donepezil Following Positive Pre-IND Communication From FDA 5/3/2016
Tesaro (TSRO) Announces Submission Of Investigational New Drug Application For Anti-TIM-3 Antibody TSR-022 To The FDA 4/25/2016
NanoCor Therapeutics Announces FDA Acceptance Of Investigational New Drug (IND) For Carfostin 4/20/2016
Selvita Files IND Application For Its Novel, Dual PIM/FLT3 Inhibitor In AML 4/18/2016
Neovacs Obtains South Korea Health Authority Approval For IND Application With Infa Kinoid In Lupus 4/14/2016
Adaptimmune (ADAP) Announces FDA Acceptance Of IND Application For Affinity Enhanced T-Cell Therapy Targeting AFP In Liver Cancer 4/7/2016
CANBridge Life Sciences Submits Investigational New Drug Application To Taiwan Food And Drug Administration For CAN-008 Phase I/II Trial In Glioblastoma 4/7/2016
Hansa Medical: FDA Clears Hansa Medical’s IND Application For IdeS In Kidney Transplantation 4/4/2016
Evofem Files IND For Evaluation Of Prevention Of Recurrence Of Bacterial Vaginosis 3/31/2016
Regen BioPharma Submits IND Application To FDA On tCellVax, A Checkpoint Inhibitor For Cancer Therapy 3/23/2016
FDA Lifts Partial Clinical Hold on Medivation (MDVN)'s Pidilizumab 3/9/2016
Titan Pharma (TTP) Receives Feedback From FDA On Ropinirole Implant Development Program For Parkinson's Disease 3/8/2016
3SBio Inc. (SSRX)'s PEG-irinotecan Wins IND Approval From China FDA 3/7/2016
KemPharm Files IND For KP511, An Investigational Prodrug Of Hydromorphone 3/7/2016
InDex Pharmaceuticals AB Receives FDA Clearance Of IND For Cobitolimod (Kappaproct) Phase IIb Trial 3/7/2016
CTD Holdings, Inc.' Clinical Program To Move Forward In The U.S. 2/29/2016
Portage Biotech's Biohaven Announces Expedited Development Path For BHV-0223 Following Successful Pre-IND Interaction With FDA 2/25/2016
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



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