FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway ...
Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
The Hill4d
FDA approves first new UTI drug in decades
The Food and Drug Administration (FDA) has approved a new drug for treating urinary ... if it occurs in a female individual who does not have a fever, is not pregnant, does not have a condition ...
MedTech Dive4d
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, ...
JD Supra6d
FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP ...