The Pharmacy Times® Retail Clinical Role section is a comprehensive resource for clinical news and expert insights on issues pertaining to retail, community, and independent pharmacists.
January 23rd 2025
The fast-track designation follows the FDA orphan drug designation that was granted for DYNE-101 in September 2023 for the same treatment population.
January 23rd 2025
FDA Accepts Supplemental New Drug Application for Tapinarof Cream, 1%, in Atopic Dermatitis
April 29th 2024The acceptance is based on positive data from the phase 3 ADORING 1 and ADORING 2 pivotal trials, as well as interim results from the phase 3 ADORING 3 open-label, long-term extension trial.
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FDA Approves Pivmecillinam for Treatment of Female Adults With Urinary Tract Infections
April 24th 2024Pivmecillinam (Pivya; UTILITY therapeutics Ltd) tablets were approved for female adults with uncomplicated urinary tract infection caused by Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
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