Archive - April 2025
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma
FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
Depemokimab Applications Accepted for Review by the US FDA for Asthma with Type 2 Inflammation and for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy
Tolebrutinib Regulatory Submission Accepted for Priority Review in the US for Patients with Multiple Sclerosis
FDA Grants Priority Review for Biologics License Application (BLA) for Apitegromab as a Treatment for Spinal Muscular Atrophy
FDA Issues Complete Response Letter for Etripamil for PSVT
Otsuka Files Biologics License Application (BLA) for Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy