The U.S. Food and Drug Administration on Thursday made recommendations to vaccine manufacturers for the virus strains to be ...

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 ...

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...

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

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

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

Active surveillance using routine health data can improve patient safety The US Food and Drug Administration (FDA) requires manufacturers of medical devices, such as ventilators and defibrillators, to ...

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

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Significant progress in HYLA blood sensor and INSPIRA ART core technologies RA'ANANA, Israel, March 11, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd.

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