FDA Approvals, News & Updates

On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have received ≥1 previous lines of therapy. Read More ›

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 ›

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