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

FDA's NDA And BLA Approvals: Xultophy, Soliqua

Executive Summary

Original new drugs and biologics recently approved by US FDA.

You may also be interested in...



Novo Nordisk, Sanofi Insulin Combo Products Clear US Regulatory Hurdles

US FDA approves Xultophy and Soliqua, both fixed-ratio combinations of a basal insulin and a GLP-1 agonist, on the same day even though Sanofi redeemed a priority review voucher that earned Soliqua an earlier user fee goal date.

Bluebird’s Zynteglo Approval Kicks Off Commercial Operations

Bluebird bio’s Tom Klima told Scrip launch preparations are well under way, including negotiations with payers on outcomes-based reimbursement agreements.

AbbVie Halts Another Trial With I-Mab Antibody, Slashes Deal Size

AbbVie is to terminate the clinical development of lemzoparlimab for myelodysplastic syndrome and acute myelocytic leukemia and will also reduce the size of its 2020 deal with originator I-Mab by $445m, in the latest blow to the Chinese firm.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS119570

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