Pink Sheet 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.

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
My View
Tags:
Review Pathway Research & Development Drug Review

Priority Reviews At US FDA: From Third Quarter Spikes To A Third Quarter Trough

  • Analysis

Executive Summary

Priority review announcements saw significant dip in third quarter 2018, while they usually experience a spike during the period; breakthrough therapy designations remained in double digits.

You may also be interested in...



Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track: A Long-Awaited Approval For Generic EpiPen, Cancer Product Labels Expand And Constrict

The latest drug development news and highlights from our US FDA Performance Tracker. 

Breakthrough Therapy Designations Set Quarterly Record

US FDA granted designations for several products based on late-stage data; with at least 19 breakthrough therapy designations, five-year-old program sets another record in first quarter of 2018.

Table

View full table

Related Content

Pink Sheet
Pink Sheet

Topics

Related Companies

Tags:
Review Pathway Research & Development Drug Review
Latest Headlines

Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

Partisan Politics Returns To US FDA Congressional Oversight

GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows

Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development

See All
UsernamePublicRestriction

Register

PS123981

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