FDA News

The end of another quarter means a new list of FDA-approved drugs for conditions treated in primary care. Are you up-to-date? Click through to find out.

The Dexcom G7 continuous glucose monitoring system provides an overall MARD of 8.2%, the highest of any FDA-cleared CGM, the company says.

The FDA has granted priority review to a biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate, RSVpreF, for adults aged ≥60 years.

The FDA amended Pfizer and Moderna EUAs for updated COVID-19 vaccines to include children as young as age 6 months as holidays and winter weather approach.

The Agency's priority review of the prescription-OTC switch underscores the urgent need for broader access to the opioid overdose reversal agent.

The single-dose biotherapeutic remained effective through 6 months for more than 90% of phased 3 clinical trial participants, according to Ferring Pharmaceuticals.

Your daily dose of clinical news you may have missed.

Your daily dose of clinical news you may have missed.

Teplizumab, an anti-CD3 monoclonal antibody, delayed the median onset of stage 3 T1D by approximately 2 years compared to placebo in a pivotal clinical trial.

A preliminary assessment from the FDA suggests certain naloxone products may be safely used without a prescription to prevent opioid overdose deaths.