logo
Plus   Neg
Share
Email

Sanofi: FDA Issues CRL For Zynquista

Sanofi (SNYNF,SNY) said that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

Sanofi and Lexicon will work closely with the FDA to determine the appropriate next step.

For comments and feedback contact: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon Inc. is leading a new $575 million investment in British food delivery company Deliveroo, intensifying the e-commerce giant's competition with rival Uber and its Uber Eats service. Deliveroo noted that Amazon is set to be the largest investor in the Series G preferred shared funding round. With the latest funding round, Deliveroo has raised $1.53 billion. While reporting financial results for the first quarter on Friday, Deere & Co. (DE) slashed its earnings and revenue growth guidance for the full-year 2019. The company said the lower forecast is partly a result of actions taken by it to prudently manage field inventories, which will cause production... European Union regulators on Thursday fined five global banks a total of 1.07 billion euros, or $1.2 billion, for participating in foreign exchange spot trading cartels and manipulating the foreign-exchange currency market. The five banks are Barclays, Royal Bank of Scotland, Citigroup, JPMorgan Chase and Japan's MUFG Bank, formerly known as Bank of Tokyo-Mitsubishi.
Follow RTT