FDA to review Sanofi, Regeneron’s Dupixent sBLA for CSU
The FDA has set a target action date of 18 April 2025 for its decision. If approved, Dupixent is expected to become the first targeted CSU therapy in
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Ractigen Therapeutics' new therapy, RAG-21, targeting the fused in sarcoma (FUS) gene, for amyotrophic lateral sclerosis (ALS) treatment.
The BLA is sought for treating NSCLC patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR) who have received systemic therapies previously. Concurrently, the companies have
This partnership leverages SpectronRx’s advanced facilities for late-stage clinical and commercial supplies of the therapy. SpectronRx and Plus Therapeutics collaboration is set to accelerate nuclear medicine and improve
This epinephrine sublingual spray is designed for emergency situations. The FDA’s feedback could potentially lead the company to a New Drug Application (NDA) submission. The FDA-approved epinephrine prodrug