The UK Commission Wants L-Plates for AI and an End to One-Time Approval
Coverage is calling these new AI rules. What they propose is replacing the single approval decision with supervised entry and permanent monitoring.
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Years After NCCN Recommended It, FET-PET Finally Has an FDA-Approved Drug
The clinical case was settled before the regulatory one. Clinicians held an NCCN recommendation with no lawful product to act on it.
Korea adds Pergoveris pen to reimbursement rolls, vial already covered
This is a device listing, not an eligibility expansion. The indication is unchanged, and the criteria were relaxed back in April 2025.
CDA-AMC reverses course, backs Leqembi’s first ruling content still undisclosed
Four words carry the news: follows a reconsideration. CDA-AMC reached a different conclusion first, and neither release says what it was.
Nine More Drugmakers Signed MFN Deals. The Coalition Formed to Fight Them Did Not.
The useful information is who is absent. The mid-sized biotech coalition formed to contest MFN has no member among the nine signatories.
Korea Runs Three Reimbursement Speeds. September Shows All Three at Once.
The lane determines the timeline, and it is set long before you file. Model the Korean queue, not the approval date.
3 of 1,357 Cleared AI Devices Have Public Outcome Trials. The Study Has No Non-AI Comparator.
The census counts publicly registered evidence, so it measures disclosure. Without a non-AI comparator it cannot show this is an AI problem.
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
Abbott Cleared the First Dual Glucose and Ketone Sensor. FDA Judged Accuracy, Not Admissions.
The label says diabetes. The clinical argument is type 1. Coverage conversations start from 2.1 million people, not 40.1 million.
This Money Buys Equipment, Not Operations. Your 2031 Answer Decides the 2027 Deal.
Half the pot is split equally, so award size is a weak proxy for market size. Your buyer is a state rural health office, not a hospital.