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