Tag: Drug Approvals
FDA Approves Voquezna for Erosive Esophagitis, GERD
Phase 3 trial showed noninferiority versus lansoprazole in healing and maintenance phases
FDA Approves Zilbrysq for Generalized Myasthenia Gravis
Approval granted for once-daily, self-administered treatment in patients with anti-acetylcholine receptor-antibody-positive disease
FDA Approves Nivolumab as Adjuvant Treatment for Melanoma
Approval granted for patients aged 12 years and older with stage IIB/C disease
FDA Approves Velsipity for Moderate-to-Severe Ulcerative Colitis in Adults
Significant benefits at 12 weeks include clinical remission, endoscopic improvement, mucosal healing
FDA Approves Updated Novavax COVID-19 Vaccine
Updated shot is expected to better target variants that are circulating now and help prevent hospitalization and death from the virus
Even Five Years Postapproval, Many Drug Studies Remain Nonpublic
Authors urge greater transparency of study results for drugs approved by the FDA
First Biosimilar Approved to Treat Multiple Sclerosis
Tyruko, biosimilar to Tysabri (natalizumab) injection, approved for treatment of clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
FDA Approves Akeega for BRCA-Positive Metastatic Prostate Cancer
Akeega plus prednisone significantly improves radiographic progression-free survival in patients with castration-resistant prostate cancer
FDA Provides Accelerated Approval of Talvey for Multiple Myeloma
Talvey, a bispecific therapy, indicated for the treatment of patients with relapsed, refractory, heavily pretreated multiple myeloma
FDA Approves Izervay for Geographic Atrophy Tied to Age-Related Macular Degeneration
Two trials show significant slowing of geographic atrophy progression at the 12-month primary end point
