Artificial intelligence is no longer on the horizon of medical device regulation — it’s already on regulators’ desks. The FDA’s iterative guidance on AI/ML-based Software as a Medical Device (SaMD), the EU AI Act’s risk classification scheme, and Health Canada’s...
Precision medicine works when the right biomarker test reaches the right patient in time. In Europe, the regulatory plumbing is making that harder than it should be. At the 16th Clinical Biomarkers & CDx Summit in London in March 2026, I discussed lessons from MDx...
Two FDA decision dates, 18 September and 27 November, are now the most important dates on GSK's calendar. On 9 June 2026, the British pharmaceutical giant announced it had agreed to acquire Cambridge, Massachusetts-based Nuvalent for $10.6 billion in cash, securing...
Workplace Bullying in Healthcare and the Leadership Response Healthcare is one of the most demanding professional environments on earth. Clinicians make high-stakes decisions under pressure, routinely absorb the grief and trauma of others, and operate within systems...
The biosimilar market in 2026 is delivering on years of regulatory groundwork, and the numbers tell a striking story. Since the first US biosimilar was approved in 2015, the sector has generated more than $56 billion in healthcare savings, according to Cardinal...
Trump FDA Drug Approvals: How US Regulatory Upheaval Is Reshaping the Global Pharmaceutical Industry The United States Food and Drug Administration has long been regarded as the gold standard of drug regulation. When a medicine receives FDA approval, it carries a...
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