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 officials Vinay Prasad and Marty Makary have unveiled a new “plausible mechanism pathway” designed to accelerate bespoke gene-editing therapies.
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’s Tzield gains FDA review for stage 3 T1D.
FDA defines biosimilar PAS & CBE under BsUFA III
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
FDA import ban issued on Olympus medical devices from Japan for quality violations.
FDA investigates Elevidys deaths, raising new safety and regulatory questions for gene therapies.
PathPresenter wins FDA clearance for digital pathology viewer, advancing primary diagnosis and LIS integration.
FDA De Novo nod for TISSIUM’s COAPTIUM CONNECT: a new era in sutureless nerve repair.