A Mexico City startup has achieved the Western Hemisphere's first SaMD regulatory approval for its proprietary AI-powered ...

FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups Phase 3 trial shows mNEXSPIKE outperforms original ...

The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

A breakthrough nerve therapy is improving stroke survivors' mobility and quality of life. A UConn doctor is asking the state ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 ...

Sleep Better Columbus is now offering FDA-cleared oral appliance therapy for patients diagnosed with mild to moderate ...

Vivani Medical is developing GLP-1 subdermal implants that aim to provide a consistent therapeutic dose for six months, and ...

Business schools expand STEM to meet job demands in finance Medical device company raises $7 million to support FDA approval ...

Nevada Attorney General Aaron D. Ford has issued a consumer alert urging residents to be cautious of misleading marketing ...

BiVacor announced today that it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system.

As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...