Latest Regulatory News News

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

BPH Energy has responded to ASX inquiries about unusual trading activity, confirming no undisclosed information and highlighting ongoing Federal Court proceedings related to the PEP 11 project.

Radiopharm Theranostics has secured FDA Fast Track designation for RAD101, a novel imaging agent aimed at improving diagnosis of recurrent brain metastases. The move could speed development and regulatory review as the company advances its Phase 2 clinical trial.