Pink Sheet is part of the Business Intelligence Division 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.

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
UsernamePublicRestriction

Dapagliflozin’s CV Profile Shines, But FDA Panel Review Falls On Cancer Concerns

Executive Summary

The July 19 FDA advisory committee meeting on Bristol-Myers Squibb Co./AstraZeneca PLC's dapagliflozin reflects the hurdles facing type 2 diabetes drug sponsors even when cardiovascular safety concerns are taken out of the picture.
Advertisement

Related Content

AstraZeneca’s Farxiga Label Includes, But Downplays, Bladder Cancer Risk
FDA Panel Questions Role Of CV Safety Meta-Analyses At Dapagliflozin Review
Dapagliflozin Passes CV Safety Test For Now; FDA Panel Eyes Outcomes Study
FDA Panel To Weigh Dapagliflozin Bladder Cancer, CV Safety Questions
SGLT-2 Inhibitor Dapagliflozin Gets Another Chance At FDA
FDA Advisory Committee Waivers Reflect Recruitment Challenges
Stringent Hepatic Monitoring Urged For Diabetes Drug Clinical Trials
Stringent Hepatic Monitoring Urged For Diabetes Drug Clinical Trials
Dapagliflozin Cancer Signal Weighs Heavily In FDA Panel's Negative Vote
FDA's Dapagliflozin Review To Focus On Hepatic Effects, Cancer Risks

Topics

Advertisement
UsernamePublicRestriction

Register

PS053614

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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