FDA News

Dupilumab Becomes First Biologic Approved in the US as Targeted Therapy for Adults with COPD
September 27, 2024

Dupilumab represents the first new treatment approach for uncontrolled COPD in more than a decade and reduced disease exacerbations by 34% in clinical trials.

FDA Approves First-in-Class Schizophrenia Drug, Described as "Quantum Leap Forward"
September 27, 2024

Cobenfy, previously KarXT, is the first new agent with a novel mechanism of action for schizophrenia in more than 50 years, according to BMS.

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.