FDA Approval
FDA Approval
08/10/2026
Anthony Calabro, MA
The FDA approved the norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo, Viatris Inc), a once-weekly combined hormonal contraceptive patch, based on phase 3 data on efficacy, safety, and...
08/10/2026
FDA Alert
FDA Alert
01/17/2026
Kate Young
The FDA approved two new oral therapies to treat uncomplicated urogenital gonorrhea. Both treatments demonstrated comparable effectives when compared to standard treatment.
01/17/2026
Screening
Screening
11/07/2019
After performance data showed 95% sensitivity and specificity, the FDA authorized the assay’s marketing in the United States for detection of HIV-1 drug-resistant mutations.
11/07/2019