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FDA Approvals, News & Updates

Mitomycin gel (Jelmyto), an alkylating drug, is the first and only FDA-approved treatment for patients with low-grade upper-tract urothelial cancer (UTUC), a rare cancer that affects the lining of the urinary system, and offers a nonsurgical treatment alternative for patients with this rare disease. Although the majority of urothelial cancers occur in the bladder, UTUC is part of a group of urothelial cancers that arise in the lining of the kidney or the ureter.
On August 16, 2019, the FDA approved upadacitinib (Rinvoq, AbbVie) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
On August 26, 2019, the FDA approved a new indication for ixekizumab (Taltz; Eli Lilly) for the treatment of patients with active ankylosing spondylitis (AS). Ixekizumab has received previous FDA approval for the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as for the treatment of patients with active psoriatic arthritis.
On August 16, 2019, the FDA approved upadacitinib (Rinvoq, AbbVie), a Janus kinase inhibitor, for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
On July 24, 2019, the US Food and Drug Administration approved adalimumab-bwwd (Hadlima; Samsung Bioepis), a biosimilar to adalimumab (Humira; AbbVie) for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.
  • Ixekizumab Approved for Adults with Psoriatic Arthritis
  • Biosimilar to Infliximab Approved for All Eligible Indications of Reference Drug
  • Tofacitinib and Tofacitinib Extended Release Approved for Adults with Psoriatic Arthritis
Tocilizumab is the first therapy approved by the FDA for the treatment of adult patients with this type of vasculitis, and was granted Breakthrough Therapy designation and Priority Review for this indication.
Dr Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs, and as Senior Advisor to the FDA Commissioner.
  • Adalimumab Biosimilar Approved to Treat Multiple Indications
  • First Drug for Duchenne Muscular Dystrophy Granted Accelerated Approval
  • FDA Approves Etanercept Biosimilar for Multiple Indications
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