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.
Tag Archive for: Refusal to File letter
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.