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.

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

Keeping Track: US FDA Clears Two More Biosimilars, First Non-Injectable Glucagon

Executive Summary

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

You may also be interested in...



Troriluzole Fails First Phase III Test As Biohaven Looks Beyond Migraine

Biohaven is still studying its glutamate modulator in three other indications, but its biggest near-term milestone will be approval of the oral CGRP inhibitor rimegepant for acute migraine.

Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be "deemed" BLAs in six months; agency is working on a policy to address the transition of authorized generic insulins to regulation under the PHS Act, Office of Therapeutic Biologics And Biosimilars acting policy director Eva Temkin says.

Keeping Track: US FDA Approvals For Ibsrela, Gvoke And Nucala; A BTD For Tepotinib

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

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS140581

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