FDA Approvals, News & Updates

On April 13, 2021, the FDA accelerated the approval of sacituzumab govitecan (Trodelvy; Immunomedics), a Trop-2 antibody and topoisomerase inhibitor, for patients with locally advanced or metastatic urothelial cancer who had received a platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor. The FDA had granted sacituzumab govitecan a breakthrough therapy designation for this indication. Read More ›

On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)- positive lesions in men with prostate cancer. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›

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. Read More ›


  • 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
Read More ›

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. Read More ›

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