• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pipeline

Pipeline

April 29, 2019
Company Drug/Device Medical Condition Status
Innovent Biologics, Inc. and Eli Lilly & Company IBI318 advanced malignancies Phase I trial initiated enrolling subjects in China
TC BioPharm TCB002 Acute Myeloid Leukemia (AML) Phase I trial initiated enrolling 9 subjects in Prague, Czech Republic
Innovent Biologics, Inc. IBI302 wet age-related macular degeneration (wet AMD) Phase I trial initiated enrolling 36 subjects
Vaxiion Therapeutics, Inc. VAX014 non-muscle invasive bladder cancer (NMIBC) Phase I trial initiated
Indalo Therapeutics IDL-2965 nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF) Phase I trial initiated
Galapagos NV, MorphoSys AG and Novartis Pharma AG MOR106 in combination with topical corticosteroids moderate to severe atopic dermatitis Phase II trial initiated enrolling 60 subjects
Forbius AVID100 EGFR-overexpressing Triple Negative Breast Cancer (TNBC) Phase IIa trial initiated enrolling 100 subjects
Evofem Biosciences, Inc. Amphora sexually transmitted bacterial infections Phase IIb trial initiated enrolling more than 850 female subjects who had been treated for chlamydia or gonorrhea in the preceding four months
TaiGen Biotechnology Company, Limited Furaprevir in combination with Yimitasvir chronic hepatitis C Phase III trial initiated enrolling 360 subjects with both cirrhotic and non-cirrhotic genotype 1 in China
GlycoMimetics, Inc. uproleselan Acute Myeloid Leukemia (AML) Phase III trial initiated enrolling 250 subjects with relapsed/refractory AML
Mallinckrodt, plc Acthar Gel (Repository Corticotropin Injection) Systemic Lupus Erythematosus (lupus, SLE) Phase IV trial initiated enrolling 172 subjects with persistently active SLE
Beckman Coulter Early Sepsis Indicator sepsis 510(k) clearance granted by the FDA
TELA Bio, Inc. Restella Reconstructive BioScaffolds reconstructive surgery 510(k) clearance granted by the FDA
Repro-Med Systems, Inc. HIgh-Flo Super26 Subcutaneous Needle Sets subcutaneous infusion of medications 510(k) clearance granted by the FDA
Akorn, Inc. Fluticasone Propionate Nasal Spray temporary relief of hay fever and other upper respiratory allergies in adult and pediatric subjects 4 years of age and older ANDA approval granted by the FDA
Akorn, Inc. Loteprednol Etabonate Ophthalmic Suspension, 0.5% post-operative inflammation following ocular surgery ANDA approval granted by the FDA
Moleculin Biotech, Inc. Annamycin relapsed or refractory acute myeloid leukemia (AML) Fast Track designation granted by the FDA
GENFIT elafibranor Primary Biliary Cholangitis (PBC) in adult subjects with inadequate response to ursodeoxycholic acid (UDCA) Breakthrough Therapy designation granted by the FDA
Viela Bio inebilizumab neuromyelitis optica spectrum disorder (NMOSD Breakthrough Therapy designation granted by the FDA
Knopp Biosciences, LLC dexpramipexole hypereosinophilic syndrome (HES) Orphan Drug designation granted by the FDA
NeuroSigma, Inc. Monarch eTNS System (Monarch) attention deficit hyperactivity disorder (ADHD) Clearance to market granted by the FDA
BAROnova, Inc. TransPyloric Shuttle (TPS) Device obesity Approval granted by the FDA
Boston Scientific Corporation LOTUS Edge Aortic Valve System severe aortic stenosis Approval granted by the FDA
AbbVie SKYRIZI (risankizumab-rzaa) moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy Approval granted by the FDA
Merck KEYTRUDA in combination with Inlyta (axitinib) advanced renal cell carcinoma (RCC) Approval granted by the FDA
Teva Pharmaceutical Industries Ltd. generic naloxone hydrochloride nasal spray opioid overdose Approval granted by the FDA

 

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • tablet

    Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

  • Diversity-360x240.png

    Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing