• 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

October 29, 2018
Company Drug/Device Medical Condition Status
Regeneron Pharmaceuticals and Sanofi Dupixent (dupilumab) as an add-on maintenance therapy Moderate-to-severe asthma Granted approval by the FDA
Eiger BioPharmaceuticals, Inc. lonafarnib Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies Granted Rare Pediatric Disease (RPD) designation by the FDA
Abbott HeartMate 3™ Left Ventricular Assist Device (LVAD) Advanced heart failure Granted approval by the FDA
Bristol-Myers Squibb Combination of Opdivo and Yervoy Peviously untreated advanced or metastatic renal cell carcinoma (RCC) Yielded a significantly longer treatment-free survival period than sunitinib, the standard of care, in Phase III clinical trial
Takeda Pharmaceutical Company Investigational subcutaneous formulation vedolizumab Moderately to severely active ulcerative colitis Significant portion of patients in Phase III VISIBLE 1 clinical trial show achieved clinical remission
Roche Xofluza (baloxavir marboxil) Flu in patients 12 years of age and older Granted approval by the FDA
Incyte Corporation ruxolitinib (Jakafi®) Acute graft-versus-host-disease (GVHD) inpatients with inadequate response to corticosteroids FDA accepted its supplemental New Drug Application (sNDA) for priority review
Scarless Laboratories, Inc. Novel therapeutic peptide, SLI-F06 Scar reduction Granted clearance by the FDA to enter a Phase I/IIa clinical trial
CStone Pharmaceuticals Monoclonal antibody (mAb) CS1003 Cancer FDA approved company's Investigational New Drug (IND) application
Avita Medical RECELL® Autologous Cell Harvesting Device (RECELL® System) Superficial partial- and mid-thickness pediatric burns, including scald injuries Beginning of a randomized, controlled clinical trial
Seqirus AFLURIA® QUADRIVALENT (Influenza Vaccine) Flu in patients six months and older Granted approval by the FDA

Upcoming Events

  • 12Apr

    The Participant Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 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

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

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

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

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