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.
By therapy area
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.
RK-251 Was Tested Against One Cancer Cell Line. The Problem It Was Built to Solve Is Bioavailability.
FindingsScience read/Oncology/Small Molecule RK-251 Was Tested Against One Cancer Cell Line. The Problem It Was Built to Solve Is Bioavailability. Athithi Verma· 25 August 2026· 2 min read· Synopulse What they did A research article in the Journal of Medicinal Chemistry, published 23 July 2026 across pages 17342 to 17365. Kesarwani and colleagues at IIT … Read more
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.
Trodelvy Now Covers First-Line TNBC Across PD-L1 Status. The Two Regimens Are Not Equally Tolerated.
Serious adverse reactions ran at 38% in the combination trial against 26% in the monotherapy trial. Same drug, same line, different companion.
Rett Syndrome Gets Its First EU Treatment. Thirty Pricing Negotiations Start Now.
First and only is not the same as available. One authorisation covers 30 jurisdictions, each of which now prices the drug separately.
NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option
QuickAccess read/Endocrine & Metabolic/Peptide NICE Backed a Weekly Insulin Before It Has a Licence, Then Told Prescribers to Pick the Cheapest Option Athithi Verma· 25 August 2026· 2 min read· Synopulse NICE published final draft guidance recommending insulin efsitora alfa (Onswik), from Eli Lilly, for adults with type 2 diabetes. Given once weekly by pre-filled … Read more
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.
Canada Moved Two Cancer Drugs Forward in One Week. Neither Went the Normal Route.
One drug reached review only because payers filed for a manufacturer that had not. The other was recommended on evidence the committee called inconclusive.
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.