FDA News

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.

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.