On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National ...

Drug Eluting Stents are anticipated to lead the product category, holding 34.5% of the market revenue in 2025. Their clinical demand stems from their ability to prevent restenosis and maintain ...

Infuse for TLIF initially received FDA breakthrough device designation in April 2024. A new indication could expand treatment options for spine surgery patients if approved, Medtronic says. The ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Proposals include establishing "indirect recognition" of EU CE-marked devices to the UK market and "international reliance" ...

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

The U.S. Food and Drug Administration announced a sweeping initiative on Wednesday to revoke or propose revocation of 52 food standards it deems obsolete or unnecessary. The move, ...

The final, formatted version of the article will be published soon. The SARS-CoV-2 (COVID-19) pandemic highlighted the critical role of pharmacovigilance in ensuring vaccine and drug safety. This ...

British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the use of its respiratory syncytial virus (RSV) vaccine to adults under the ...