FDA’s BsUFA III Framework: What It Means for Biosimilar Sponsors
FDA defines biosimilar PAS & CBE under BsUFA III
News
Focus Brief: Market Access Weekly September 1 to 7, 2025
Global market access shifts: HTA speed, UK pricing, digital disruption.
The Big Bet: Health Care Deal Spotlight for September 1 to 7, 2025)
Healthcare deal spotlight September 1 to 7, 2025
NCPE Recommends Conditional Access for Omeprazole
NCPE recommends Omeprazole Appizped for reimbursement eligibility.
NCPE Recommends Vabysmo, Signaling Retinal Policy Shift
NCPE recommends Vabysmo for neovascular (wet) age-related macular degeneration treatment.
J&J Launches AI in Surgery Funding via Polyphonic™ Fund
J&J invests $100M in AI in surgery funding to drive smarter surgical solutions.
Kymera Strikes License Agreement Deals With Sanofi, Gilead
Sanofi, Gilead sign License Agreement with Kymera for protein degrader programs.
Stryker’s Incompass Total Ankle Wins FDA Clearance
Stryker FDA-cleared InCompass Ankle; protein degrader partnerships drive innovation.
Hereditary Angioedema Drug From CSL Gains German Backing
Hereditary angioedema therapy by CSL Behring gains positive nod in Germany.
FDA Import Ban Disrupts Olympus’ US Medical Supply
FDA import ban issued on Olympus medical devices from Japan for quality violations.