Tag Archive for: Refusal to File letter

The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.

BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.

BrainStorm Cell Therapeutics ran into another stumbling block with ALS hopeful NurOwn Thursday as the FDA issued a Refusal to File Letter for its Biologics License Application.

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.