- In December 2024, UroGen Pharma Ltd. announced the presentation of the Phase 3 ENVISION trial’s efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. In the study, UGN-102 treatment showed an 82.3% (95% CI: 75.9%, 87.1%) duration of response (DOR) at 12 months, according to the Kaplan-Meier estimate, in patients who achieved a complete response (CR) at 3 months following the initial treatment with UGN-102.
- In Oct 2024, Zydus Lifesciences announced that, it has received approval from the US health regulator to produce a generic prostate cancer treatment drug. The company has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide tablets (40 mg and 80 mg), the drug maker said in a regulatory filing.
- In Oct 2024, Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cephalexin Tablets USP, 250 mg. The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Keflet Tablets, 250 mg and 500 mg, of Eli Lilly and company. The product will be launched in Q3FY25.
- In June 2024, Palatin Technologies, Inc. announced the launch of a Phase 2 clinical study for bremelanotide (BMT), a melanocortin 4 receptor (MC4R) agonist, when co-administered with a phosphodiesterase 5 inhibitor (PDE5i) to treat erectile dysfunction (ED) in patients who do not respond to PDE5i monotherapy. Topline results from the Phase 2 study are anticipated by the end of 2024.
- In April 2024, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for treating uncomplicated urinary tract infections (UTIs) in adult females, caused by susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. Uncomplicated UTIs are bacterial infections of the bladder in women without any structural abnormalities in the urinary tract. The FDA approval of Pivya was granted to UTILITY Therapeutics Ltd.
