Tag: Drug Approvals
FDA Approves Bimzelx for Three New Indications
New indications include active psoriatic arthritis, nonradiographic axial spondyloarthritis with objective signs of inflammation, and ankylosing spondylitis
FDA Approves Injectable Ocrevus Zunovo for Relapsing, Progressive MS
Phase 3 data show efficacy and safety profile similar to intravenous administration
FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis
Approval is for new, first-line biologic treatment of eczema that is not well controlled with topicals in people 12 years and older
FDA Approves Tremfya for Ulcerative Colitis
Approval is for adults with moderately to severely active disease
Time From Drug Approval to Reimbursement Longer in U.S. Than Some European Countries
France has highest reimbursement rate one month after approval, while U.S. and Germany had no drugs reimbursed at one month
FDA Approves Nemluvio for Prurigo Nodularis
Clinical trials show significant benefits for itch, skin nodules, and sleep disturbance versus placebo
FDA Approves Voranigo for Grade 2 Astrocytoma or Oligodendroglioma
This is the first FDA-approved systemic therapy for patients with a susceptible IDH1 or IDH2 mutation
FDA Approves Darzalex Faspro for Treating Multiple Myeloma
The quadruplet regimen was approved for stem cell transplant-eligible patients
FDA Approves Tecelra as First Gene Therapy for Synovial Sarcoma
The T-cell receptor gene therapy is approved for adults with unresectable or metastatic synovial sarcoma
FDA Approves Leqselvi for Severe Alopecia
JAK inhibitor associated with significant improvements in scalp hair coverage at 24 weeks
