Tag: Drug Approvals
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
FDA Approves Zoryve for Atopic Dermatitis
The once-daily, nonsteroidal cream is approved for adults and children 6 years and older
FDA Expands Approval for Duchenne Muscular Dystrophy Gene Therapy
Approval allows for use in nonambulatory individuals ≥4 years with a confirmed gene mutation
FDA Expands Pediatric Indication for Rinvoq
Rinvoq can now be used in patients 2 years of age and older with polyarticular juvenile idiopathic arthritis or pediatric psoriatic arthritis
FDA Approves KEYTRUDA + Chemo for Primary Advanced, Recurrent Endometrial Carcinoma
Significant reductions in disease progression or death seen with both mismatch repair-proficient and -deficient cases
