FDA News

7 Drugs Approved for Primary Care: Q3 2024
September 26, 2024

Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.

FDA Approves Lebrikizumab-lbkz for Moderate to Severe AD: Daily Dose
September 24, 2024

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

First Self-Administered Flu Vaccine Approved by US FDA
September 20, 2024

FluMist is the first influenza vaccine that does not have to be given by a health care professional.

FDA Grants Emergency Use Authorization for Updated Novavax COVID-19 Vaccine
September 03, 2024

The updated COVID-19 vaccine targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2.

FDA Clears Tubeless Automated Insulin-Delivery System for Adults with Type 2 Diabetes
August 27, 2024

The Omnipod 5 is now the first automated insulin delivery system available for both T1D and T2D in the US.

FDA Grants Approval, EUA for Updated mRNA COVID-19 Vaccines
August 22, 2024

The updated COVID-19 vaccines will include a monovalent component corresponding to KP.2, a strain of the Omicron variant of SARS-CoV-2.

FDA Approves Neffy as First Nasal Spray for Allergic Reactions: Daily Dose
August 20, 2024

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

First At-Home, OTC Syphilis Test Granted Marketing Authorization by FDA
August 19, 2024

The First to Know Syphilis Test detects a current or past infection, regardless of successful treatment, in 15 minutes using a drop of blood.

PTSD Treatment: Brexpiprazole plus Sertraline May be First New Option for Patients in 2 Decades
August 15, 2024

The FDA recently accepted the sNDA for brexpiprazole in combination with sertraline and set a PDUFA target action date for February 2025.

Novel Blood Test for CRC Screening Receives FDA Approval: Daily Dose
August 15, 2024

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