Japan Approved Orladeyo for Under-Twelves in an Open-Label Interim Analysis of 29 Children
The molecule has been approved in Japan since 2021. What is new is a formulation a two-year-old can swallow, and that is the commercial move.
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Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
ASCO’s First ctDNA Guideline Found Few Instances of Clinical Utility. Residual Disease Got No Recommendation at All.
Most of the guideline concerns where ctDNA should not be used. The application carrying the largest commercial expectations got no recommendation.
Roche Cleared an Alzheimer’s Blood Test With Three Result Categories. The Middle One Is Where PET Survives.
A three-way result means some patients resolve neither way, and those still go to imaging. Roche has not said how many land in the middle.
FDA Moved a Class of Cancer Tests From PMA to 510(k). Fewer Than Five Parties Commented.
The order moves these tests from PMA to 510(k). One special control was deleted, and the predicate chain is where the change compounds.
In Ustekinumab Biosimilars, Approval Stopped Being the Hard Part
A biosimilar licence used to be the scarce asset. In ustekinumab it is the entry ticket, and the returns go to whoever solves supply and device.
Two FDA Device Authorisations, Two Sets of Evidence Narrower Than the Headline
Aletta matches human phlebotomists only when it agrees to attempt a draw. Narwhal cleared on bench and animal data, citing a trial with a different probe.
MHRA Puts Microbiome Medicines Inside the Existing Framework While the EU Builds a Separate One
No bespoke regime is coming. Microbiome medicines meet the standard biological bar in the UK, while the EU builds a separate SoHO framework.
PDUFA VIII Keeps Every Review Clock and Hires Four Auditors
Industry renegotiated what it pays FDA without changing what it gets. The clocks held. What expanded is the apparatus for verifying the money buys reviewers.
A Third Centiloid Scale Just Cleared. The First Two Already Disagree at the Threshold.
Cortechs.ai clears NeuroQuant PET for Centiloid amyloid quantification, entering a field where the two incumbent scales differ by more than 10 Centiloids.