Regulatory
FDA Approval Process Explained: How Drugs Get From Clinical Trials to Market
Every drug in your medicine cabinet survived the same gauntlet. Years of research, thousands of patients, hundreds of millions of dollars, and a final verdict
Coverage of FDA decisions, advisory committees, submissions, guidances, policy changes, and global regulatory developments shaping the health science industry.
Every drug in your medicine cabinet survived the same gauntlet. Years of research, thousands of patients, hundreds of millions of dollars, and a final verdict
The healthcare sector is experiencing a profound transformation as industry giants restructure, pricing pressures intensify, and strategic acquisitions reshape the competitive landscape. Johnson & Johnson
The FDA just dropped draft recommendations that could fundamentally change how cell and gene therapies (CGT) get developed and approved. The new guidelines emphasize adaptive
The United States has initiated Section 232 national security investigations into imports of medical equipment, personal protective equipment (PPE), and medical devices, sending shockwaves through
The FDA just released guidance aimed at accelerating non-opioid pain treatment development, and it could be a game changer for companies working on novel analgesics.
The World Health Organization just made a decision that could reshape global access to some of the world’s most sought-after medications. By adding GLP-1 receptor
HHS directive linked to BARDA funding scale-back reflects shifting pandemic priorities and mRNA policy changes Vaxart has laid off 10% of its staff after the
Brinsupri becomes groundbreaking DPP1 inhibitor therapy addressing decades of unmet medical need in rare respiratory disease Insmed Corporation achieved a historic regulatory milestone with FDA
President Trump to discuss policies boosting domestic drug production and innovation investment The White House announced plans for President Trump to meet with pharmaceutical industry
Voluntary early-review initiative shifts to preventive manufacturing quality oversight The FDA launched a new “Pre-Check” voluntary program allowing pharmaceutical manufacturers to undergo proactive quality systems