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Merck's DOR/ISL met primary efficacy and safety goals in two Phase 3 HIV trials. Marketing applications are planned for ...

The study found that just 20% of trials submitted to both the FDA and European Medicines Agency had matching evidence.

Stereotaxis (STXS) announced FDA regulatory submission for the MAGiC Sweep catheter. MAGiC Sweep is the first high-density EP mapping catheter ...

Key regulatory trends laying the foundation for updated policies, risk-based regulatory frameworks, and forward-looking ...

With what analysts are calling "strong" data, Amgen plans to file a regulatory submission for Uplizna, currently approved for ...

Exploring Regulatory Affairs, the discipline dedicated to ensuring that new drugs and biologics are safe, effective, and ...

In the Phase III trial, 41.9% of pediatric Tourette syndrome patients relapsed after ecopipam treatment, as compared with ...

During the third quarter of fiscal year 2025 ("Q3 FY2025”) and to date in 2025, HeartSciences has seen material progress towards FDA submissions of our products and there have been significant ...

Cameron Hoyler is the general counsel, corporate secretary, and executive vice president of PolarityTE, Inc., a Nasdaq-listed ...