FDA News

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.

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

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

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

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

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

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

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.

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

Three falsified batches of semaglutide (Ozempic) are in circulation, posing risks for ineffective treatment due to incorrect dosing, contamination, and use of unknown ingredients, warned WHO.