WHO Regional Director for Europe, Dr Hans Henri P. Kluge, described the achievement as a “major step forward for public health” and a strong indicator of leadership in the region.
Access to life-saving medicines often depends not only on scientific breakthroughs, but on how quickly and efficiently regulatory systems can evaluate and approve them.
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
SYDNEY, Dec. 31, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (KZIA), an oncology-focused drug development company, today provided a regulatory update on paxalisib for the treatment of glioblastoma ...
Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory requirements across different regions are hindering cell and gene therapy (CGT ...
RIYADH, SAUDI ARABIA, February 5, 2025 / EINPresswire.com / -- The Chief Executive Officer of the Saudi Food and Drug Authority (SFDA), H.E. Dr. Hisham S. Aljadhey, contributed his insights to a ...
Gerard Barron, Chairman and CEO, announced the company’s decision to pursue a new regulatory pathway under the U.S. Deep Seabed Hard Mineral Resources Act (DSHMRA), aimed at accelerating commercial ...
A key objective of medicines regulatory authorities is to protect public health by ensuring the quality, safety and efficacy of medicines. Medicines regulatory authorities use mutual ...
This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...
Prevention of Renarcotization after Rescue from Opioid Overdose is a New Indication and Planned Clinical Studies will be Supported by Pioneering a First-of-Its-Kind, Capital Efficient, Modeling and ...
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