Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Orphan Disease Clinical Trial Grants Aim To Reduce Financial Risk

Executive Summary

Agency awards $22m to support 15 clinical trials and approximately $10m for six natural history studies in rare diseases. FDA Commissioner Gottlieb highlights the program as a way for the agency to help de-risk clinical development.

You may also be interested in...



Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says

US FDA officials say they need knowledge of the disease to have the confidence to use accelerated approval.

Keytruda's New Tissue-Agnostic Indication Could Prompt Orphan Policy Changes

US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.

RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates

Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

SC099624

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel