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FDA and CMS align to fast-track Medicare device coverage

The US FDA and CMS have launched the RAPID pathway to accelerate Medicare coverage for certain breakthrough medical devices by aligning regulatory and reimbursement processes earlier in development.

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

Moving Biotech secures FDA Fast Track for 4P004 targeting knee osteoarthritis with synovitis after failure of at least two ...
TMCnet

Polaryx Therapeutics Receives U.S. FDA Fast Track Designations for All Four Indications to be Evaluated in the SOTERIA Basket Trial

Following the March 2026 grant of FTD to PLX-200 in treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease), PLX-200 now holds FTD for all four prospective indications to be ...
News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
Taiwan News

Aligos Therapeutics Announces First Interim Analysis Results from the Phase 2 B-SUPREME Study of Pevifoscorvir Sodium in Participants with Chronic Hepatitis B Virus Infection ...

Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection; HBeAg- cohort sample size increased to optimize powering; fu ...
Nasdaq

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, ...