Changes in the form of layoffs and new leadership have come to Aeglea Biotherapeutics. Wednesday morning, the Texas-based company announced that Anthony Quinn has stepped down from his role as chief executive officer and transitioned to an advisory role.
Tag Archive for: Biologics License Application
In what has been a long time coming, Tel Aviv and New York-based BrainStorm announced Monday that it would submit a Biologics License Application (BLA) to the FDA for NurOwn as a potential treatment for ALS. Simultaneously, BrainStorm announced corrected analyses it says strengthen its original conclusions.
The company’s original plan was to not apply to regulators until 2023, but now, it plans to submit the drug to the FDA in the next few months, with plans to launch the drug in mid-2023.
Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the Biologics License Application (BLA) to Nov. 17.