FDA’s Surgical Robot Guidance Prefers Robotic Comparator Data, Which Mostly Means Measuring Challengers Against Intuitive
One test for every surgical robot, and by preferring robotic comparators it decides whose results set the score.
FDA
Merck’s $4 Billion Daiichi ADC Pact Takes Its Third FDA Setback in Three Years
The $4bn deal’s first return keeps slipping toward 2028, the year Keytruda begins to lose protection.
Lilly’s New Combination Beats its Own Monotherapy
Median PFS doubled to 11.1 months against Inluriyo alone. The comparison payers will run is not in the package.
Synopulse Weekly Pulse: Access Decisions, Regulatory Events & Market Dynamics, Week of Nov 10, 2025
The Week’s Biggest Shifts in Payer Strategy This week’s policy and access landscape was defined by a sweeping overhaul of U.S. Medicaid drug pricing and a widening push toward value-driven reimbursement models. CMS’ newly announced GENEROUS model, paired with Most Favored Nation (MFN) pricing agreements for GLP-1s, marks a structural shift that will reshape affordability … Read more
FDA Unveils Plausible Mechanism Pathway to Accelerate Bespoke Gene Editing Therapies
FDA officials Vinay Prasad and Marty Makary have unveiled a new “plausible mechanism pathway” designed to accelerate bespoke gene-editing therapies.
FDA Unveils Second Wave of National Priority Voucher Winners, Featuring Obesity Leaders Lilly and Novo Nordisk
Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.) FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies The U.S. Food and Drug Administration (FDA) has announced a significant … Read more
Sanofi Secures Breakthrough FDA Review for Tzield
Sanofi’s Tzield gains FDA review for stage 3 T1D.
FDA’s BsUFA III Framework: What It Means for Biosimilar Sponsors
FDA defines biosimilar PAS & CBE under BsUFA III
Stryker’s Incompass Total Ankle Wins FDA Clearance
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
FDA Import Ban Disrupts Olympus’ US Medical Supply
FDA import ban issued on Olympus medical devices from Japan for quality violations.