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 ...
US FDA approves Sanofi's bleeding disorder therapy
The U.S. Food and Drug Administration approved French drugmaker Sanofi's hemophilia therapy, introducing a new type of ...
BioPharma Dive2d
FDA approves first-of-its-kind RNA drug for hemophilia
The Sanofi drug, known as fitusiran and now Qfitlia, was approved on Friday for a broad group of people with the rare ...
The American Journal of Managed Care2d
FDA Approves Fitusiran for Reducing Bleeds in Patients With Hemophilia A/B
Data from the ATLAS research comprises a series of trials that have yielded years of long-term, comprehensive data on safety ...
FDA approves first new UTI drug in decades
The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug ...
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, ...
Medscape2d
FDA Approves Fourth Denosumab Biosimilar
Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...
FDA approves new drug to treat protein buildup in the heart
The FDA has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra ...
MPR2d
FDA Approves Blujepa for Uncomplicated UTI in Female Patients
Gepotidacin is an oral, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by blocking 2 different type II topoisomerase enzymes.
MedCity News4d
FDA Approves First-in-Class GSK Antibiotic for Common Type of Urinary Tract Infection
A GSK pill that offers a lower potential for drug resistance is now FDA approved as a new treatment for a common type of urinary tract infection, the first new oral antibiotic for this indication ...