Rylaze™ (asparaginase erwinia chrysanthemi [recombinant]rywn) – New orphan drug approval

The FDA announced the approval of Jazz Pharmaceuticals’ Rylaze (asparaginase erwinia chrysanthemi [recombinant]¬rywn), as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. June 30, 2021

Keytruda® (pembrolizumab) – Indication withdrawal

Merck announced that the company plans to voluntarily withdraw the accelerated approval indication for Keytruda (pembrolizumab) July 1, 2021

Solosec® (secnidazole) – New indication

Lupin Pharmaceuticals announced the FDA approval of Solosec (secnidazole), for the treatment of trichomoniasis caused by Trichomonas vaginalis (T. vaginalis) in adults. July 1, 2021