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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.

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 ...

Investors are encouraged to read the Company's Annual Report on Form 10-K when it is filed with the Securities and Exchange ...

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 ...

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

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

With this regulatory submission, Stereotaxis is taking a critical ... Stereotaxis submitted a 510(k) application for MAGiC Sweep with the FDA and expects to submit MAGiC Sweep for European CE ...

Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the "Company" or "Quoin"), a late clinical-stage specialty pharmaceutical company focused on rare and orphan ...