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

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

Stereotaxis STXS recently submitted an application seeking FDA regulatory clearance for its MAGiC Sweep catheter, which is ...

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

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

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

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

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps ...

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

Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...