FDA News

FDA Approves Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections
October 25, 2024

Oral sulopenem is the first oral penem approved in the US for treating uUTIs in women with limited options.

FDA Expands Indication for RSV Vaccine Abrysvo to Include Adults Aged 18 to 59 with Chronic Conditions
October 23, 2024

Pfizer announced the FDA approval on October 22 that makes Abrysvo now the RSV immunization with the broadest indication for adults, the company said.

FDA Updates Flublok Label with Safety Data for Pregnant Individuals
October 23, 2024

The safety data used to update the Flublok label is from a study of more than 48 000 pregnant women across multiple flu seasons, according to Sanofi.

FDA Grants Priority Review to GSK NDA for First-In-Class Oral Antibiotic
October 16, 2024

The FDA today accepted GSK's NDA for gepotidacin for the treatment of uncomplicated urinary tract infections in women and adolescents.

FDA Approves Next-Gen Noninvasive CRC Screening Test: Daily Dose
October 16, 2024

Your daily dose of the clinical news you may have missed.

FDA Faces Law Suit Over Sudden Removal of Tirzepatide from Drug Shortage List
October 15, 2024

Update: The FDA has told compounding pharmacies they may resume production of tirzepatide products while the agency further investigates supply.

FDA Grants Marketing Authorization to First OTC Flu/COVID-19 Test Outside Emergency Use Declaration
October 08, 2024

The non-prescription test has more than 95% sensitivity and specificity for SARS-COV-2 and influenza A and B and delivers results in approximately 15 minutes.

FDA Approves First-Ever Biologic Medicine for COPD: Daily Dose
October 08, 2024

Your daily dose of the clinical news you may have missed.

FDA Approves First-in-Class Schizophrenia Drug: Daily Dose
October 07, 2024

Your daily dose of the clinical news you may have missed.

FDA Approves First Self-Administered Flu Vaccine: Daily Dose
September 30, 2024

Your daily dose of the clinical news you may have missed.