FDA News

FDA Approves First Blood Test for Primary Screening of Colorectal Cancer
August 07, 2024

The Shield blood test is approved for primary CRC screening in adults 45 years and older at average risk for the disease.

Bayer Submits NDA to FDA for Elinzanetant for Treatment of VMS
August 06, 2024

The submission is based on data from OASIS trials that showed elinzanetant significantly reduced the frequency and severity of moderate-to-severe VMS associated with menopause.

FDA Approves First Orally Disintegrating Tablet for Birth Control: Daily Dose
August 05, 2024

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

FDA Warns Clinicians of Adverse Events due to Overdosing of Compounded Semaglutide
July 30, 2024

Lack of dosing experience and errors with converting measurement units may lead to overdosing, the agency reported.

FDA Declines Approval of High-Dose Naloxone Rescue Medication, OX124 for a Second Time
July 17, 2024

The FDA requested an additional human factors study and more technical data on the final commercial product.

7 Drugs Approved for Primary Care: Q2 2024
July 11, 2024

ICYMI: A quick look at 7 key drugs FDA-approved in the second quarter for conditions commonly seen in primary care.

FDA Approves Donanemab for Early Symptomatic Alzheimer Disease: Daily Dose
July 10, 2024

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

FDA Approves Ensifentrine for Maintenance Treatment of COPD in Adults: Daily Dose
July 08, 2024

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

FDA Gives Green Light to Ensifentrine for Maintenance Treatment of COPD in Adults
June 27, 2024

The dual PDE3/PDE4 inhibitor is the first inhaled product with a novel mechanism of action approved for COPD in 2 decades and is delivered via standard jet nebulizer.

Dapagliflozin Approved for Treatment of T2D in Children: Daily Dose
June 26, 2024

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