Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
Report Store
UsernamePublicRestriction
Tags:
BioPharmaceutical United States Regulation

CBER's Dozen: Novel Biologics Approved In 2015

  • Analysis

Executive Summary

An interactive chart listing the novel biologics cleared by FDA's Center for Biologics Evaluation and Research in 2015.

You may also be interested in...



Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA’s Median Review Time For Novel Drugs Held Steady In 2020

Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

Breakthroughs, Orphans Hit High Notes As US FDA’s 2020 Novel Approvals Play A Familiar Tune

Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.

Table

View full table

Topics

Tags:
BioPharmaceutical United States Regulation
UsernamePublicRestriction

Register

OM004634

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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

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